Syringes and injector devices are among the most widely used medical tools, serving critical roles in drug administration, fluid aspiration, diagnostic procedures, and specialized interventions such as angiography or ophthalmic injections. Their design ranges from simple piston syringes to advanced automated injectors with software integration.

Intended Use of Syringes

Syringes are intended for the controlled administration or withdrawal of fluids in medical, dental, and surgical settings. Depending on design, they may be used for:

Drug delivery (e.g., insulin pens, epinephrine auto‑injectors).

Diagnostic sampling (e.g., vacuum syringes for blood collection).

Specialized procedures (e.g., angiographic balloon inflation, ophthalmic injections).

Dental applications (e.g., irrigating syringes, cartridge syringes for anesthesia)

Fibrin Sealant Preparation Device (Piston Syringe)

Intended Use: Used to prepare and deliver fibrin sealant components (fibrinogen and thrombin) for surgical hemostasis.

Device Description: This is a dual‑chamber piston syringe that keeps fibrinogen and thrombin separate until the point of use. It has a specialized mixing tip that combines the two components during injection, ensuring controlled delivery. The design supports sterile, single‑use application in surgical environments where precise hemostasis is critical.

Syringe, Piston

Intended Use: General‑purpose injection or aspiration of fluids.

Device Description: A conventional syringe consisting of a cylindrical barrel, a plunger with a piston tip, and a luer connector for attachment to needles or tubing. It is available in multiple volumes to suit different clinical applications. The design allows for accurate administration or withdrawal of fluids in routine medical practice.

Syringe, Antistick

Intended Use: Prevents accidental needle‑stick injuries during injection.

Device Description: This syringe incorporates safety mechanisms such as retractable needles or sliding shields. These features automatically or manually cover the needle after use, reducing occupational exposure risks. The design enhances user safety without compromising injection accuracy.

Syringe, Piston, Reprocessed

Intended Use:Injection or aspiration of fluids in medical procedures.

Device Description: A previously used piston syringe that has undergone validated cleaning, disinfection, and sterilization processes in accordance with applicable regulatory requirements. The reprocessing activities are intended to remove biological and chemical contaminants while maintaining the functional characteristics of the device. Functional performance verification is conducted following reprocessing, and the device is labeled to indicate its reprocessed status.

Injector, Pen

Intended Use: Self‑administration of drugs such as insulin.

Device Description: A Pen‑style Injector with a replaceable or pre‑filled cartridge. It incorporates a dosing dial and spring‑driven plunger mechanism for precise subcutaneous delivery. The ergonomic design allows patients to administer medication independently and consistently.

Epinephrine Syringe

Intended Use: Emergency treatment of anaphylaxis.

Device Description: A pre‑filled, single‑use syringe containing epinephrine solution. It is designed for rapid intramuscular administration during life‑threatening allergic reactions.

Vacuum Syringe

Intended Use: Aspiration of fluids using vacuum assistance.

Device Description:

This syringe uses a vacuum‑assisted mechanism to facilitate sample collection or fluid withdrawal. It provides consistent suction compared to manual aspiration. The design is often used in diagnostic or laboratory procedures requiring controlled fluid removal.

Piston Syringe Lever

Intended Use: Facilitates controlled injection.

Device Description: A syringe with a lever‑actuated piston that allows ergonomic control of fluid delivery. The lever mechanism provides steady pressure and reduces operator fatigue. It is particularly useful in procedures requiring prolonged or precise injection.

Midazolam Syringe

Intended Use: Delivery of midazolam for sedation.

Device Description: A pre‑filled syringe containing midazolam solution. It is designed for rapid and accurate administration in procedural sedation or anesthesia. The ready‑to‑use format reduces preparation time and ensures dosing accuracy.

Piston Syringe with Neuraxial Connector

Intended Use: Injection into epidural or cerebrospinal fluid spaces.

Device Description: A syringe fitted with neuraxial‑specific connectors to prevent misconnections with IV or enteral lines. The connector design ensures safe drug delivery into sensitive anatomical sites. It is used in anesthesia and pain management procedures.

On‑Body Injector

Intended Use: Automated drug delivery over time.

Device Description: A wearable injector adhered to the skin, programmed to deliver medication subcutaneously in a controlled manner. It is often used for biologics requiring extended infusion. The device combines mechanical and electronic components for precise dosing.

Ophthalmic Syringe

Intended Use: Injection into ocular tissues.

Device Description: A syringe designed for precision delivery of drugs into the eye. It often uses fine‑gauge needles to minimize trauma. The ergonomic design supports delicate ophthalmic procedures requiring high accuracy.

Low Dead Space Piston Syringe

Intended Use: Minimizes drug waste during injection.

Device Description: This syringe is engineered with reduced residual volume to ensure maximum medication delivery. The design minimizes waste, which is especially important for expensive or limited‑supply drugs. It maintains standard functionality while improving efficiency.

Injection Data Capture Device

Intended Use: Records injection parameters such as dose and time.

Device Description: A syringe or accessory with electronic capability to log injection events. It may integrate with hospital IT systems for monitoring and documentation. The device supports traceability and enhances clinical workflow.

Syringe, Balloon Inflation (Angiographic)

Intended Use: Inflation of angioplasty balloons.

Device Description: A high‑pressure syringe designed to inflate and deflate angioplasty balloons with precise control. It is built to withstand significant pressure without leakage. The device ensures safe and effective balloon inflation during vascular procedures.

Injector and Syringe, Angiographic, Balloon Inflation, Reprocessed

Intended Use: Inflation and deflation of angioplasty balloons during vascular procedures.

Device Description: A previously used angiographic balloon inflation syringe that has undergone validated cleaning, disinfection, and sterilization processes. The reprocessing is designed to reduce contamination risks and prepare the device for its intended clinical use within defined limits. Functional performance testing is performed following reprocessing, and the device is labeled to indicate its reprocessed status.

Angiography/Angioplasty Kit

Intended Use: Diagnostic and therapeutic vascular procedures.

Device Description: A sterile kit containing syringes, catheters, and accessories required for angiography or angioplasty. It is packaged to streamline procedural setup. The kit ensures sterility and convenience for clinicians.

Angioscopic Valvulotome Kit

Intended Use: Cutting venous valves during angioscopy.

Device Description: A kit that includes a valvulotome and syringe components. It is designed for vascular surgical interventions requiring precision. The sterile packaging supports safe and efficient use in operating rooms.

Syringe, Balloon Inflation, Exempt

Intended Use: Balloon inflation in angioplasty.

Device Description: A simplified balloon inflation syringe variant subject to reduced regulatory requirements. It provides controlled inflation and deflation of angioplasty balloons. The design is straightforward but effective for its intended use.

Injector and Syringe, Angiographic

Intended Use: Contrast medium injection in angiography.

Device Description: A syringe/injector system designed for controlled delivery of contrast agents into the vasculature. It is built to handle high pressures safely. The design ensures accurate and consistent contrast administration.

Injector, Contrast Medium, Automatic

Intended Use:  Automated injection of contrast agents.

Device Description: A programmable injector that delivers contrast media at controlled rates during imaging procedures. It integrates electronic controls for precision. The device improves consistency and safety in radiology.

Injector, Contrast Medium, Automatic, Reprocessed

Intended Use: Automated delivery of contrast media during diagnostic imaging procedures.

Device Description: A previously used automatic contrast injector that has undergone validated cleaning, disinfection, and sterilization processes in accordance with regulatory requirements. The device undergoes functional verification to confirm appropriate operation after reprocessing. Labeling clearly identifies the device as reprocessed.

Injector and Syringe, Angiographic, Reprocessed

Intended Use: Delivery of contrast media during angiographic procedures.

Device Description: A previously used angiographic injector or syringe system that has undergone validated reprocessing, including cleaning, disinfection, and sterilization. The reprocessing process is intended to reduce contamination risks and restore the device for its intended clinical function. Functional testing is performed following reprocessing, and the device is labeled accordingly.

Enteral Syringes with Enteral‑Specific Connectors

Intended Use: Administration of enteral nutrition or medications.

Device Description: Syringes fitted with ENFit or similar connectors to prevent misconnections with IV lines. They are designed for safe delivery into the gastrointestinal tract. The connectors enhance patient safety by eliminating cross‑connection risks.

Pump, Infusion or Syringe, Extra‑luminal

Intended Use: Used in hemodialysis systems to manage extracorporeal fluid infusion.

Device Description: This is a syringe pump integrated into dialysis equipment, designed to regulate fluid flow outside the body. It provides precise control of infusion rates, ensuring safe and effective dialysis treatment. The pump is engineered for compatibility with hemodialysis circuits and long‑term reliability.

Syringe, Cartridge

Intended Use: Delivery of dental anesthetics.

Device Description: A reusable syringe designed to hold anesthetic cartridges for dental procedures. It provides precise dosing and controlled delivery of anesthetic agents. The ergonomic design allows dentists to administer anesthesia safely and efficiently.

Syringe, ENT

Intended Use: Administration of drugs into the ear, nose, or throat.

Device Description: A syringe specifically designed for ENT applications, often with specialized tips for mucosal delivery. It allows accurate placement of medication in delicate anatomical areas. The design supports safe and effective treatment in otolaryngology.

Ear Irrigation Kit

Intended Use:  Irrigation of the ear canal.

Device Description: A kit that includes an irrigating syringe and accessories for safe removal of earwax or debris. It provides controlled fluid flow to avoid damage to the ear canal. The kit is packaged for convenience and sterile use in clinical or home settings.

Syringe, Irrigating (Non‑Dental)

Intended Use:  Irrigation of wounds or body cavities.

Device Description: A syringe designed for flushing wounds or cavities with sterile solutions. It typically features blunt tips to minimize tissue trauma. The design ensures effective cleansing while maintaining patient safety.

Unit, Syringe, Air and/or Water

Intended Use: Dental cleaning and irrigation.

Device Description: A dental handpiece unit that delivers streams of air or water through a syringe mechanism. It is used for cleaning, rinsing, and drying during dental procedures. The design integrates with dental chairs and supports efficient workflow.

Syringe, Irrigating (Dental)

Intended Use: Irrigation in dental procedures.

Device Description: A syringe used for rinsing and cleaning during dental treatments. It allows precise delivery of irrigating solutions into the oral cavity. The design supports easy handling and effective removal of debris.

Syringe, Periodontic/Endodontic Irrigating

Intended Use: Irrigation in periodontal and endodontic therapy.

Device Description: A specialized dental syringe with fine tips for targeted irrigation of periodontal pockets or root canals. It ensures effective cleaning of hard‑to‑reach areas. The design minimizes patient discomfort while improving treatment outcomes.

Syringe, Restorative and Impression Material

Intended Use: Delivery of dental restorative or impression materials.

Device Description: A syringe designed to dispense viscous dental materials into prepared cavities or moulds. It provides controlled extrusion to ensure accuracy. The design supports consistent placement of restorative or impression compounds.

Performance Testing for Syringes

• Freedom from Extraneous Matter
• Lubricant Quantification
• Graduation Accuracy
• Dead Space
• Air Leakage
• Liquid Leakage
• Piston Operation Force (Break‑loose and Glide)
• Plunger Stopper Fit and Retention
• Barrel Strength
• Nozzle Strength
• Electromagnetic Compatibility (EMC) and Electrical Safety testing (e.g., automatic injectors, on-body injectors).

• Software Verification & Validation and Cybersecurity testing (e.g., injection data capture devices, automated contrast injectors).

• Biocompatibility Tests (based on the nature and duration of patient contact).
• Cytotoxicity Testing
• Sensitization Testing
• Irritation Testing
• Systemic Toxicity Testing
• Pyrogenicity
• Hemocompatibility

• Sterilization and Packaging Validation

• Shelf-life study

Clinical Testing:

Clinical data is not required for the 510(k) submission