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

    KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES

    K Number: K950434 · Decision Mar 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    73
    Applicant Total
    334
    Review Days
    55

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    Basic Information

    Device Name
    KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
    K Number
    K950434
    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
    February 2, 1995
    Decision Date
    March 29, 1995
    Product Code
    OCZ
    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
    OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

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    K201135 Image1 S CCU, Image1 S 4U Camera Head
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    K191357 Flexible HD Cysto-Urethroscope System
    K182723 Flexible HD Cysto-Urethroscope System
    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
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