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

    XENON ARC ENDOSCOPE LIGHT SOURCE

    K Number: K920403 · Decision Feb 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    30
    Review Days
    21

    Basic Information

    Device Name
    XENON ARC ENDOSCOPE LIGHT SOURCE
    K Number
    K920403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDICAL DEVICE INSPECTION CO., INC.
    Date Received
    January 31, 1992
    Decision Date
    February 21, 1992
    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

    Similar 510(k) Clearances

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

    Disposable Trocars

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

    8 mm Assist Cannula; 12 mm Assist Cannula

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

    Boehringer Laboratories Liver Retractor

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

    Medical Monitor (32HS710S)

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

    Arthrex Synergy Vision Endoscopic Imaging System

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

    LAGIS Suction Irrigation System

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

    Other Clearances by MEDICAL DEVICE INSPECTION CO., INC.

    K Number Device Name
    K945826 J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
    K932072 JARIT SURGICAL INSTRUMENTS
    K931594 THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM
    K933580 POWER WORK TABLE
    K933578 POWERMATIC MAT PLATFORM
    K933581 POWERMATIC TREATMENT TABLE
    K933577 POWERMATIC EXAMINATION TABLE
    K922045 SHOWER CHAIRS
    K912075 C-SECTION TRAY
    K914174 STERILE DISPOSABLE WET SKIN SCRUB TRAY
    Search all 30 clearances from MEDICAL DEVICE INSPECTION CO., INC. →