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

    DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR

    K Number: K021747 · Decision Aug 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
    K Number
    K021747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgicon, Inc.
    Date Received
    May 28, 2002
    Decision Date
    August 15, 2002
    Product Code
    GCI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCI Laryngoscope, Endoscope

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    Other Clearances by Surgicon, Inc.

    K Number Device Name
    K033359 DEGALL II GALLBLADDER EXTRACTOR