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

    SURGITRON

    K Number: K911461 · Decision Apr 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SURGITRON
    K Number
    K911461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Ellman Intl. Mfg., Inc.
    Date Received
    April 3, 1991
    Decision Date
    April 25, 1991
    Product Code
    GCI
    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
    GCI Laryngoscope, Endoscope

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GCI), ordered by most recent decision date.

    DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KARL STORZ 3D VIDEO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIRTCHER SURE CLEAN INSTRUMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BOOTY ENDOSCOPE WARMER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Ellman Intl. Mfg., Inc.

    K Number Device Name
    K914329 SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION