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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: OCW FDA class 2

    Endoscopic Tissue Approximation Device

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Tissue Approximation Device (product code OCW) is a gastroenterology and urology device used to aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue during minimally invasive GI and GU procedures. Tissue approximation is used for wound closure, hemostasis, and anatomical repair within body cavities. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SimpleStitch Suturing System
    MaxTack™ Motorized Fixation Device
    MedicloseTM System
    OverStitch NXT Endoscopic Suturing System
    endomina system
    Su2ura Approximation Device
    OverStitch Sx Endoscopic Suturing System
    AbClose - Port Site Closure Device
    OverStitch 2-0 Polypropylene Suture
    OverStitch Endoscopic Suturing System and Accessories
    MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
    CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
    OverStitch SX Endoscopic Suturing System (ESS)
    AbClose - Port Site Closure Device
    Miret Grasper, Alligator, Miret Grasper, Maryland
    MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
    WECK EFX ENDO FASCIAL CLOSURE SYSTEM
    ACE STAPLER AND CARTRIDGE
    ACE STAPLER AND CARTRIDGE
    G-CINCH SUTURE GRASPER
    AXIOM FASCIAL CLOSURE SYSTEM
    MINI-TONG
    ACE STAPLER, MODEL F0031
    ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
    AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
    SILS STITCH ENDOSCOPIC SUTURING DEVICE
    MODIFIED ENDO STICH
    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
    ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
    PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
    INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
    OPUS SMARTSTITCH SUTURE DEVICE
    MINI LAP INSTRUMENTS
    MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
    ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
    OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
    ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
    SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
    ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
    REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
    SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE
    SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
    TACKER, MODEL R65-933
    PARE ENDOSCOPIC SUTURING SYSTEM
    ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
    SMITH & NEPHEW SUTURELOK, MODEL 7207321
    SUPERSTITCH
    SMITH & NEPHEW SUTURE LOK
    ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
    UROMED NEEDLE GRASPER

    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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