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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: GEN FDA class 1

    Forceps, General & Plastic Surgery

    General, Plastic Surgery

    View full classification →

    Forceps for General and Plastic Surgery (product code GEN) are manual handheld grasping instruments used across a broad range of general and plastic surgery procedures to hold, manipulate, or retract tissue and surgical materials. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only with no premarket notification required. Regulated under 21 CFR 878.4800 and assigned to the General, Plastic Surgery specialty (SU), this instrument carries no special regulatory flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    NATURALASE LP ND:YAG LASER
    FORCEPS
    SUTURE REMOVING FORCEPS
    FORCEPS
    PALPATION PROBE
    GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
    GS-1500 CLAW FORCEP, 10MM
    GS-1200 GRASPING/EXTRACTING FORCEP, 10MM
    GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP
    TISSUE FORCEPS, VARIOUS TYPES
    HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT
    CAMPION LASER FORCEPS
    FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL
    MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)
    GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)
    NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS
    NSN #6515-00-333-2400 ADSON DRESSING FORCEPS
    DISPOSABLE BIPOLAR FORCEPS
    MICRINS FORCEPS 2010
    VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    GRASPING FORCEP, 1.7MM
    CUP BIOPSY FORCEP, 1.7MM
    ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP
    MEDCARE FORCEPS (THUMB, TISSUE)
    PILLING HEMOSTATIC CLIP APPLIER FORCEPS
    TIP OFF FORCEPS
    SURGICAL & DENTAL INSTRUMENT
    MEDUS GMBH
    SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
    IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS
    CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420
    FORCEPS, BIOPSY(NON RIGID)
    2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS
    NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410
    51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO
    39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS
    17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI
    15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST
    17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS
    RAKA OCH BOSDA PEANGER
    DISSECTING TWEEZER #283-72PCS. SS 410
    JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42
    PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F
    MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420
    FORCEPS & HAMOSTATS
    DISPOS. & SPONGE FORCEPS PEAN ARTERY
    BIOPSY FORCEPS
    SURGICAL INSTRUMENT
    GENERAL SURGICAL INSTRUMENTS
    TISSUE FORCEPS

    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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