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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: PKL FDA class 2

    Hemostatic Metal Clip For The Gi Tract

    Gastroenterology, Urology

    View full classification →

    The Hemostatic Metal Clip For The GI Tract (product code PKL) is a Class 2 device used during endoscopic procedures within the gastrointestinal tract for purposes including endoscopic marking, hemostasis of mucosal and submucosal defects, bleeding ulcers, arteries, polyps, and diverticula, prophylactic clipping, anchoring feeding tubes, and supplemental closure of luminal perforations. It is regulated under 876.4400 and falls within the Gastroenterology and Urology specialty, requiring 510(k) clearance. The device is flagged as both an implant and a life-sustaining/life-supporting device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PADLOCK CLIP EFTR Kit (00713229)
    Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
    Haemostasis Clips
    PADLOCK CLIP EFTR Kit (00713229)
    BARS Set (100.60)
    Single Use Hemoclips
    Disposable Hemostatic Clips
    Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
    Disposable Dual Action Tissue Closure Device
    Disposable Hemostatic Clips
    Disposable Hemoclip (AF series)
    Disposable Hemoclip
    Disposable Endoscopic Hemoclip
    Disposable hemoclip
    Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
    MANTIS Clip
    Hemoclip
    CORE-CLIP
    Disposable Hemostatic Closure Clip Device
    Single Use Hemoclip
    Hemoclip
    Disposable Dual Action Tissue Clip
    Instinct Plus Endoscopic Clipping Device
    Lockado Repositionable Hemostasis Clip
    X-Tack Endoscopic HeliX Tacking System
    Single Use Rotatable and Repositionable Hemoclip
    ClearEndoclip
    Resolution 360™ ULTRA Clip
    gastroduodenal FTRD Set
    Instinct Plus Endoscopic Clipping Device
    Padlock Clip defect closure system, Padlock Pro-Select defect closure device
    stentfix OTSC System Set
    Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
    ClearEndoclip
    SureClip Repositionable Hemostasis Clip
    Single Use MultiClip Device
    Hemoclip
    Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
    Single Use Hemoclip
    FTRD System Set
    SureClip(TM) Repositionable Hemostasis Clip
    FTRD System Set
    Sterile Repositionable Hemostasis Clipping Device
    OTSC Proctology
    Resolution Clip
    Resolution Clip
    INSTINCT ENDOSCOPIC HEMOCLIP
    SINGLE USE REPOSITIONABLE CLIP
    RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
    PADLOCK CLIP-12

    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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