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

    SURGICAL VIDEO CAMERA AND ACCESSORIES

    K Number: K934682 · Decision Feb 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    18
    Review Days
    138

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    Basic Information

    Device Name
    SURGICAL VIDEO CAMERA AND ACCESSORIES
    K Number
    K934682
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Dynamics, Inc.
    Date Received
    September 30, 1993
    Decision Date
    February 15, 1994
    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 Medical Dynamics, Inc.

    K Number Device Name
    K974542 TRUE VISION, TRUE VISION II
    K921294 VIDEO ENDOSCOPE-RIGID MODIFICATION
    K930568 ADAIR/VERESS NEEDLE INTRODUCER SET
    K915538 OVER THE WIRE STONE BASKET
    K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
    K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
    K911296 OPTICAL CATHETER ARTHROSCOPE
    K903339 VIDEO ENDOSCOPE, RIGID
    K904609 XENON LIGHT SOURCE
    K904113 OPERATIVE RECORDING CAMERA
    Search all 18 clearances from Medical Dynamics, Inc. →