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

    WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP

    K Number: K954649 · Decision Dec 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    73

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    Basic Information

    Device Name
    WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
    K Number
    K954649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson Greatbatch Technologies, Inc.
    Date Received
    October 10, 1995
    Decision Date
    December 22, 1995
    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 Wilson Greatbatch Technologies, Inc.

    K Number Device Name
    K971374 GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
    K971377 GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
    K972280 GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K971781 GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
    K970619 GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    K971375 GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
    K950063 WGL ENDOSCOPIC GRASPER*
    K942168 WGL ENDOSCOPIC GRASPER