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

    ENDOSCOPIC VIDEOSYSTEM

    K Number: K822959 · Decision Oct 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    10
    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
    ENDOSCOPIC VIDEOSYSTEM
    K Number
    K822959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Eder Instrument Co, Inc.
    Date Received
    October 5, 1982
    Decision Date
    October 22, 1982
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

    Similar 510(k) Clearances

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

    ProVee Video Processing Unit (PV-003)

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

    UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

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

    Endoscopic Camera System

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

    FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

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

    VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

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

    Endoscopic Video Image Processor (RP-IPD-V1000F)

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

    Other Clearances by Eder Instrument Co, Inc.

    K Number Device Name
    K843498 BIPOLAR SUCTION ELECTRODE
    K843497 SURGICAL KNIVES & PROBES
    K843499 ARTHROSCOPY LEG HOLDER
    K831255 LARYNGOSCOPE ATTACHMENT PH2000
    K831240 LASER BRONCHOSCOPE
    K831241 LASER LAPARAXOPE
    K802479 SURGICAL KNIVES & PROBES
    K792100 GRASPING FORCEP (W/FOUR PRONGS)
    K791052 ENDOSCOPIC INSTRUMENT