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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: GDW FDA class 2

    Staple, Implantable

    General, Plastic Surgery

    View full classification →

    The Staple, Implantable (product code GDW) is a surgically placed metallic staple designed to remain inside the body after a procedure, used to approximate or secure internal tissues, organs, or anastomoses in general or plastic surgery. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The device is regulated under 21 CFR 878.4750 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is intended for permanent or long-term placement within the body.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)
    ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)
    ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)
    Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
    Anika Tissue Tack Fixation System
    AEON Endoscopic Stapler
    ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)
    Disposable Endoscopic Cutter Stapler and Cartridge
    EEA Circular Stapler with Tri-Staple Technology
    Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
    Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
    GIA Auto Suture Stapler with DST Series Technology
    GIA Stapler with Tri-Staple Technology
    EEA Circular Stapler with Tri-Staple Technology
    Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
    Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
    Surgimatix Absorbable Fixation System
    easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
    Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
    Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
    Titan SGS
    Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
    EEA Circular Stapler with Tri-Staple Technology
    TissueTak device
    Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
    GIA Stapler with Tri-Staple Technology
    Tri-Staple 2.0 Reloads
    Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
    AEON Endoscopic Stapler
    Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
    Signia Stapler (with new software)
    Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
    GIA Stapler with Tri-Staple Technology
    EEA Circular Stapler with Tri-Staple Technology
    TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
    Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
    Applied Medical Laparoscopic Linear Cutter
    Reach and CQ'ENCE Circular Staplers
    Signia Small Diameter Reloads
    OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
    Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
    Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
    FasTouch Absorbable Fixation System
    easyPPHTM Hemorrhoidal Stapler for Single Use
    Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
    easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
    SignalMark Lung Biopsy Site Marker
    AEON Endoscopic Stapler
    Endoscopic Linear Cutting Staplers and Loading Units for Single Use
    Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

    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.

    Popular Product Codes

    Commonly searched
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