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

    WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA

    K Number: K951522 · Decision Jun 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    74

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    Basic Information

    Device Name
    WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA
    K Number
    K951522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Woodbine Optical Corp.
    Date Received
    April 3, 1995
    Decision Date
    June 16, 1995
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Woodbine Optical Corp.

    K Number Device Name
    K970917 SOLOS 10MM OPERATING LAPAROSCOPE
    K970056 SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
    K953086 WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA
    K940988 ACCESSORIES, SURGICAL CAMERA