Surgical Sutures FDA 510k Clearance

Absorbable & Non-Absorbable Surgical Sutures 510k

In general, surgical sutures FDA 510k clinical studies will not be needed for most surgical suture devices, FDA may recommend that you collect clinical data for a surgical suture device with:

  • a formulation dissimilar from formulations previously cleared under a FDA 510k.
  • a new technology, i.e., technology different from that used in legally marketed surgical suture devices; or
  • indications for use dissimilar from indications for use of sutures of the same type.

FDA will always consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale.

This guidance document was published on December 19, 2002, in conjunction with a Federal Register notice announcing the reclassification of the absorbable PDS suture. This 2003 guidance document supplements the December 19, 2002 “Class II Special Controls Guidance Document for 510k: Surgical Sutures; Guidance for Industry and FDA.” The FDA thinks that specific controls, in conjunction with general controls, will offer reasonable assurance of the safety and efficacy of these surgical suture devices.

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