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

    Disposable Automatic Core Biopsy Instrument

    K Number: K212284 · Decision Nov 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    4
    Review Days
    112

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    Basic Information

    Device Name
    Disposable Automatic Core Biopsy Instrument
    K Number
    K212284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Leapmed Healthcare Corporation
    Date Received
    July 21, 2021
    Decision Date
    November 10, 2021
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Suzhou Leapmed Healthcare Corporation

    K Number Device Name
    K212820 Disposable Semi Automatic Biopsy Instrument
    K212819 Disposable Biopsy Refill Needle
    K212822 Disposable Coaxial Biopsy Needle