BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM

    K Number: K990154 · Decision Jun 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    133

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    Basic Information

    Device Name
    KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
    K Number
    K990154
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Imaging, Inc.
    Date Received
    January 19, 1999
    Decision Date
    June 1, 1999
    Product Code
    FWF
    Advisory Committee
    General, Plastic Surgery
    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
    FWF Camera, Television, Endoscopic, Without Audio

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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
    K001362 KARL STORZ 3D VIDEO SYSTEM
    K994090 KARL STORZ AUTOCLAVABLE CAMERA HEAD
    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