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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: GAG FDA class 2

    Stapler, Surgical

    General Hospital

    View full classification →

    The Surgical Stapler (product code GAG) is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The device is regulated under 21 CFR 878.4740 in the General Hospital specialty (HO). No special flags apply to this device.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    AEON™ Endoscopic Powered Stapler
    da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
    Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)
    ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
    AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
    GIA™ Stapler with Tri-Staple™ Technology
    EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
    TA™ Stapler and Loading Unit with DST Series™ Technology
    Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
    ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
    PROXIMATE DISPOSABLE SKIN STAPLER
    ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
    DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
    DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES
    PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER
    REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)
    SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM
    PROXIMATE LINEAR CUTTER THICK TISSUE INST.
    HERNIASTAT
    V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
    WECK LX TM SKIN STAPLER
    PI-PHEUMO INTESTINAL INSTRUMENT SET
    V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
    APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
    V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
    APPOSE DISPOS. SKIN STAPLER W/AUTO
    APPOSE ULE STERILE DISPOS. SKIN STAP
    HYPO SUTURE
    PARAMETRIC STERILITY RELEASE OF AUTO
    PI-PNEUMO-INTESTINAL INSTRUMENT SET
    PROXIMATE DISPOSABLE SKIN STAPLERS
    DEKNATEL SKIN STAPLE EXTRACTOR
    ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER
    APPOSE SKIN STAPLER
    PROXIMATE*II DISPOSABLE SKIN STAPLER
    AUTO SUTURE DISPOS., EEA SURG. STAPLER
    SKIN STAPLER HANDLE 523700/CARTRIDGES
    PROXIMATE DISP. SKIN STAPLER
    SURGICAL STAPLING INSTRU., AUTO, SUTURE
    AUTO SUTURE R CLIP INSTRUMENT
    SKIN STAPLE EXTRACTOR
    SKIN STAPLING INSTRUMENT

    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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