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

    XENON NOPPVA

    K Number: K954561 · Decision Oct 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    334
    Review Days
    17

    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
    XENON NOPPVA
    K Number
    K954561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    October 2, 1995
    Decision Date
    October 19, 1995
    Product Code
    GCT
    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
    GCT Light Source, Endoscope, Xenon Arc

    Similar 510(k) Clearances

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

    ALPHAXENON LIGHT 180 W AND 300 W

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

    XENON-100 SCB LIGHT SOURCE, MODEL 20132620

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

    CONMED LINVATEC 300W XENON LIGHT SOURCE

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

    VIADUCT MINISCOPE AND ACCESSORIES

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

    KSEA MEDI PACK

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

    LINVATEC 300W XENON LIGHT SOURCE

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

    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
    K252624 KARL STORZ Laryngoscopes and Accessories
    K223923 HOPKINS Telescopes
    K202957 Flexible Video Cysto-Urethroscope (C-view)
    K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
    K182723 Flexible HD Cysto-Urethroscope System
    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
    Search all 334 clearances from KARL STORZ Endoscopy-America, Inc. →