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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: NAB FDA class 1

    Gauze / Sponge,Nonresorbable For External Use

    General, Plastic Surgery

    View full classification →

    Nonresorbable Gauze/Sponge for External Use is a surgical wound care product made from non-absorbable materials used to cover wounds, provide mechanical wound protection, and absorb exudate during external wound management. These products are not intended to be left inside the body. Classified as FDA Class 1, it is subject to general controls under regulation 878.4014 (General and Plastic Surgery specialty).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    IVALON EXTERNAL SPONGE
    ISOLYER (4X4, 8PLY)
    OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
    MULTI-TRAUMA DRESSING
    K-BAND AND K-CREPE
    STERILE GAUZE PADS
    GAUZE SPONGES
    ABSORBENT PAD -- MODIFICATION
    CLINISORB
    COMBINE II WETPROOF PAD
    USP TYPE VII GAUZE SPONGES
    BURN DRESSING
    TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
    MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES
    PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
    EZ GAUZE SPONGE
    MULTIPLE DRESSING, STERILE NONADDHERENT PADS
    MEPITEL NON-ADHERENT SILICONE DRESSING
    MULTIPLE BURN DRESSING
    ABSORBENT FIBER
    BANDAGE ROLL, GAUZE
    GAUZE BANDAGE ROLL
    STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
    POST OPERATIVE SPONGE
    COMPRESS DRESSING
    CONFORMING BANDAGE
    BANDAGE COMPRESS
    GAUZE COMPRESS
    GAUZE SPONGE,STERILE 2'S
    12-PLY GAUZE PAD
    STRETCH GAUZE BANDAGE
    TRIANGULAR BANDAGE,40
    ALLDRESS MULTI LAYERED WOUND DRESSING
    BACKGROUND SUCTION MATT
    HERMITEX SPONGE
    NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
    ABSORBENT GAUZE ROLL
    GAUZE BANDAGE 2 X 6 YDS.
    GAUZE BANDAGE 1 X 6 YDS.
    GAUZE BANDAGE 4 X 6 YDS.
    A-SORB
    4 X 4 SPONGES, NON-STERILE
    3 X 3 SPONGES, NON-STERILE
    TRICOTEX WOUND CONTACT LAYER DRESSING
    AN ODOR ABSORBENT BANDAGE
    PDI SURGICAL SCRUB/BRUSH T150-70
    FEMORAL CANAL SPONGE
    GAUZE BANDAGE
    GAUZE COMPRESS
    BANDAGE COMPRESS

    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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