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

    LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE

    K Number: K951990 · Decision Sep 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    134

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    Basic Information

    Device Name
    LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE
    K Number
    K951990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schoelly Technologies, Inc.
    Date Received
    April 27, 1995
    Decision Date
    September 8, 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 Schoelly Technologies, Inc.

    K Number Device Name
    K943426 ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE