BEUDAMED
    Product Code: PKL FDA class 2 21 CFR 876.4400

    Hemostatic Metal Clip For The Gi Tract

    Gastroenterology, Urology

    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.

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    510(k)s
    57
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    36
    Years Active
    28

    Basic Information

    Product Code
    PKL
    Device Class
    FDA class 2
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 57 510(k) clearances via K numbers.

    K Number Device Name
    K250842 PADLOCK CLIP EFTR Kit (00713229)
    K250066 Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
    K241005 Haemostasis Clips
    K240274 PADLOCK CLIP EFTR Kit (00713229)
    K241858 BARS Set (100.60)
    K234124 Single Use Hemoclips
    K232969 Disposable Hemostatic Clips
    K240617 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)
    K233772 Disposable Dual Action Tissue Closure Device
    K232450 Disposable Hemostatic Clips
    K231633 Disposable Hemoclip (AF series)
    K230004 Disposable Hemoclip
    K222146 Disposable Endoscopic Hemoclip
    K213217 Disposable hemoclip
    K222503 Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
    K221124 MANTIS Clip
    K213143 Hemoclip
    K213338 CORE-CLIP
    K220157 Disposable Hemostatic Closure Clip Device
    K212669 Single Use Hemoclip
    K211787 Hemoclip
    K212748 Disposable Dual Action Tissue Clip
    K212323 Instinct Plus Endoscopic Clipping Device
    K202333 Lockado Repositionable Hemostasis Clip
    K201808 X-Tack Endoscopic HeliX Tacking System
    K201771 Single Use Rotatable and Repositionable Hemoclip
    K200217 ClearEndoclip
    K193424 Resolution 360™ ULTRA Clip
    K200684 gastroduodenal FTRD Set
    K192697 Instinct Plus Endoscopic Clipping Device
    K192722 Padlock Clip defect closure system, Padlock Pro-Select defect closure device
    K183309 stentfix OTSC System Set
    K183590 Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
    K183021 ClearEndoclip
    K182556 SureClip Repositionable Hemostasis Clip
    K180325 Single Use MultiClip Device
    K172727 Hemoclip
    K180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
    K172762 Single Use Hemoclip
    K170867 FTRD System Set
    K161463 SureClip(TM) Repositionable Hemostasis Clip
    K153550 FTRD System Set
    K152001 Sterile Repositionable Hemostasis Clipping Device
    K150067 OTSC Proctology
    K151802 Resolution Clip
    K142973 Resolution Clip
    K132809 INSTINCT ENDOSCOPIC HEMOCLIP
    K123601 SINGLE USE REPOSITIONABLE CLIP
    K122660 RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
    K120814 PADLOCK CLIP-12
    K121505 DISPOSABLE HEMOSTASIS CHIP
    K102764 RESOLUTION II CLIP
    K101428 OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
    K023903 WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
    K013889 ENDOSCOPIC MULTI-FIRE CLIP APPLIER
    K990687 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
    K963160 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

    FEI Numbers

    This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.