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

    ARGUS LAPAROSCOPY INSTRUMENT SYSTEM

    K Number: K950378 · Decision Feb 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    9

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    Basic Information

    Device Name
    ARGUS LAPAROSCOPY INSTRUMENT SYSTEM
    K Number
    K950378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Argus Medical Co., Inc.
    Date Received
    January 31, 1995
    Decision Date
    February 9, 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 Argus Medical Co., Inc.

    K Number Device Name
    K950255 ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM
    K951624 ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
    K950242 ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
    K950297 ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM
    K946011 ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM