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

    KSEA SCB-RUI

    K Number: K994348 · Decision Mar 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    95
    Applicant Total
    318
    Review Days
    71

    Basic Information

    Device Name
    KSEA SCB-RUI
    K Number
    K994348
    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
    December 23, 1999
    Decision Date
    March 3, 2000
    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

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    Other Clearances by KARL STORZ ENDOSCOPY-AMERICA, INC.

    K Number Device Name
    K161554 ENDOFLATOR 40, ENDOFLATOR 50
    K162882 KARL STORZ ICG Imaging System
    K161112 KARL STORZ Flexible Video-Neuro-Endoscope System
    K152583 KARL STORZ Endoscopic ICG Imaging System
    K150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
    K143640 KSEA CMOS Camera System (C-cam)
    K142556 Flexible Video-Uretero-Choledochoscope System
    K140964 CALCULASE II
    K141250 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
    K131364 FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
    Search all 318 clearances from KARL STORZ ENDOSCOPY-AMERICA, INC. →