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

    Disposable Hemoclip

    K Number: K230004 · Decision Jul 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    8
    Review Days
    209

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Disposable Hemoclip
    K Number
    K230004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yangzhou Fartley Medical Instrument Technology Co., Ltd.
    Date Received
    January 3, 2023
    Decision Date
    July 31, 2023
    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

    Dual Action Tissue Closure Device

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

    Other Clearances by Yangzhou Fartley Medical Instrument Technology Co., Ltd.

    K Number Device Name
    K260423 Disposable Endoscopic Distal Attachments
    K250732 Disposable Endoscopy Valve Set
    K222980 Pentax Medical Valve Set
    K220785 Clean Connecting Tube
    K220292 Disposable Endoscope Injection Needle
    K220790 Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
    K220210 Disposable Endoscopy Adapter Set