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

    SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)

    K Number: K904797 · Decision Mar 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    18
    Applicant Total
    29
    Review Days
    133

    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
    SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)
    K Number
    K904797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Surgitek
    Date Received
    October 23, 1990
    Decision Date
    March 5, 1991
    Product Code
    FBO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBO Cystourethroscope

    Similar 510(k) Clearances

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

    KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

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

    KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

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

    FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE

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

    KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO

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

    ANCHORAGE SCOPE, MODEL 000003

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

    KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM

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

    Other Clearances by Surgitek

    K Number Device Name
    K946296 QUADRA-COIL URETERAL STENT
    K944391 OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
    K943491 RIGHT ANGLE UROLOGIC LASER FIBER
    K941952 SURGITEK INFUSER
    K933261 GRASPING FORCEPS
    K933260 HELICAL STONE/FLATWIRE STONE BASKETS
    K930733 URETERAL STENT
    K930483 URETERAL CATHETER
    K926344 HYDROPHILIC COATED GUIDEWIRE
    K920451 ENDOTEK ULTRA SYSTEM
    Search all 29 clearances from Surgitek →