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

    KARL STORZ 3D VIDEO SYSTEM

    K Number: K001362 · Decision Jul 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    13
    Applicant Total
    10
    Review Days
    80

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    Basic Information

    Device Name
    KARL STORZ 3D VIDEO SYSTEM
    K Number
    K001362
    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 Imaging, Inc.
    Date Received
    April 28, 2000
    Decision Date
    July 17, 2000
    Product Code
    GCI
    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
    GCI Laryngoscope, Endoscope

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    Other Clearances by Karl Storz Imaging, Inc.

    K Number Device Name
    K003325 KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
    K994090 KARL STORZ AUTOCLAVABLE CAMERA HEAD
    K990154 KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
    K974391 KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
    K973252 KARL STORZ DIRECT COUPLED CAMERA HEAD
    K963333 OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
    K950862 KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES
    K950975 KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS
    K950974 KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS