BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Dual Action Tissue Closure Device

    K Number: K250229 · Decision Sep 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    41
    Review Days
    224

    Basic Information

    Device Name
    Dual Action Tissue Closure Device
    K Number
    K250229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    January 27, 2025
    Decision Date
    September 8, 2025
    Product Code
    PKL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PKL Hemostatic Metal Clip For The Gi Tract

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PKL), ordered by most recent decision date.

    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)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Hemoclip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Taurus Clip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OTSCneo System Set (100.03n-14n, 100.27n-31n)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Hemoclip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PADLOCK CLIP EFTR Kit (00713229)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Micro-Tech (Nanjing) Co., Ltd.

    K Number Device Name
    K252492 Visualized Access and Delivery Catheter; PB Digital Controller
    K251692 Advanced Tissue Resection Device
    K243388 Disposable Distal Cap
    K243471 Extraction Basket
    K230127 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
    K221784 Single-use Video Pancreaticobiliary Scope, PB Digital Controller
    K222354 Elastic Traction System
    K213060 AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
    K220424 Through the Scope Tracheal Stent System
    K220157 Disposable Hemostatic Closure Clip Device
    Search all 41 clearances from Micro-Tech (Nanjing) Co., Ltd. →