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

    MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE

    K Number: K971150 · Decision Sep 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    179

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    Basic Information

    Device Name
    MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
    K Number
    K971150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mist, Inc.
    Date Received
    March 28, 1997
    Decision Date
    September 23, 1997
    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 Mist, Inc.

    K Number Device Name
    K970937 MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
    K952290 MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES
    K952323 MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
    K951648 MIST ENDOSCOPIC NEEDLES
    K951692 MIST ENDOSCOPIC PROBES
    K951481 MIST ENDOSCOPIC CANNULAS
    K951480 MIST TROCARS