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

    HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE

    K Number: K050163 · Decision Mar 24, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
    K Number
    K050163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Henke Sass Wolf of America, Inc.
    Date Received
    January 25, 2005
    Decision Date
    March 24, 2005
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Henke Sass Wolf of America, Inc.

    K Number Device Name
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    K030572 HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
    K013611 HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
    K991563 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
    K983067 FINE-JECT
    K981751 SINUSCOPE AND ACCESSORIES
    K962075 HSW GMBH ARTHROSCOPE
    K941541 HSV LAPAROSCOPY SET