BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Instinct Plus Endoscopic Clipping Device

    K Number: K212323 · Decision Aug 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    125
    Review Days
    30

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    Basic Information

    Device Name
    Instinct Plus Endoscopic Clipping Device
    K Number
    K212323
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    July 26, 2021
    Decision Date
    August 25, 2021
    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

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