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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: KOA FDA class 1

    Surgical Instruments, G-U, Manual (And Accessories)

    Gastroenterology, Urology

    View full classification →

    Manual Genitourinary Surgical Instruments and Accessories are hand-held surgical tools used in urological and gastrointestinal surgical procedures, including forceps, scissors, dilators, and other instruments that facilitate tissue manipulation, dissection, and access in the urinary and gastrointestinal tracts. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KOA and it is regulated under 21 CFR 876.4730 in the Gastroenterology and Urology specialty.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    FiXcision
    URETHRAL SUTURE GUIDE
    LI VASECTOMY
    VASOVASOSTOMY SET
    VESITEC SUTURE PASSER
    DDV LIGATOR
    NO-SCALPEL VASCETOMY INSTRUMENTS
    BENDEREV PROTECT-A-PASS NEEDLE
    VAS DILATOR
    GRASPING FORCEPS
    MARLOW ANAL SPECULUM
    MICROSURGICAL CYSTOTOME
    STOMACH EVACULATOR - EWALD STYLE
    MARTIN MEDICAL PRO-SCOPE ANOSCOPE
    EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
    ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
    BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
    AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
    RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
    RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
    RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
    WESTON RECTAL SNARE
    OP-CON SURG. INSTRUMENT #3
    JAKOBI SURG. INSTRUMENTS #3 21/22/24
    JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
    PROBES, VARIOUS
    P-S MEDICAL BERLIN VISADUCT KIT
    DISIMETRIC RELEASE OF INSTRANETICS RAD
    ST. MARK'S RECTAL BIOPSY FORCEPS
    URETHAL CUTTER CLAMP
    ACESSORY TO MODIFIED FREEDING JEJUNOSTO
    FORDER RETRACTOR
    FORDER RETRACTOR
    VASOVASOSTOMY STABILIZER PLATFORM DEV
    THE SCOTT DIALMENZENSERT
    CIRCLE NEPHROSTOMY TUBE INTRODUCER
    THE INQUINAL RESORVOIR INSERTER
    MAGILL CATHETER INTRO. FORCEPS
    RUDD-CLINIC HEMORRHOIDAL FORCEPS
    SYRINGE, IRRIGATION, PRE-FILLED
    ANAL/RECTAL SYRINGE
    FLEXIBLE BIOPSY FORCEPS
    FLEXIBLE CUTTING SCISSORS
    FLEXIBLE FOREIGN BODY 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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