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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: GAP FDA class 2

    Suture, Nonabsorbable, Silk

    General, Plastic Surgery

    View full classification →

    The Suture, Nonabsorbable, Silk (product code GAP) is a nonabsorbable suture made from natural silk fibers, used for wound closure and tissue approximation in general and plastic surgery procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The device is regulated under 21 CFR 878.5030 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as silk sutures are embedded within tissue during use.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    Sofsilk™ Coated Braided Silk Suture
    SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
    Non absorbable Surgical Silk Suture
    Surgical Sutures with or without Needle
    SafePath Suturing System
    FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
    SILK Surgical Suture
    FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
    WG-SURGICAL SUTURES WITH NEEDLE
    NON-ABSORBABLE SILK SUTURE
    MANI NEEDLE & SUTURE PACK (SILK)
    TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
    UNISILK
    SILK SUTURES
    DEMETECH SILK NONABSORBABLE SUTURE
    SERRALSILK
    MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
    GRAMS SILK NONABSORBABLE SUTURE
    SILK, NONABSORBABLE, SURGICAL SUTURES, USP
    SILK NONABSORBABLE SURGICAL SUTURES, USP
    SUTRASILK SILK SUTURE
    SILK
    SILK SUTURE
    SILKAM NONABSORBABLE SILK SURGICAL SUTURE
    SOFSILK SUTURE
    SOFSILK SUTURE
    SOFSILK
    SILK NONABSORBABLE SURGICAL SUTURES USP
    SURGISILK
    SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
    VISITEC PRECISE-POINT
    SUTURE NON-ABSORBABLE SILK
    SUTURE NONABSORBABLE - SILK
    SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES
    ADVANCE SUTURE NONABSORBABLE SILK SUTURE
    IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES
    NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
    NONABSORBABLE SILK SURGICAL SUTURE
    AIRWAY PRESSURE MONITOR
    RETRACTOR, GERBODE STERNAL
    NEEDLES AND SUTURES, SILK & NYLON

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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