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

    PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.

    K Number: K896680 · Decision Feb 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
    K Number
    K896680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Interson Corp.
    Date Received
    November 27, 1989
    Decision Date
    February 14, 1990
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    K911114 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
    K911464 INTERSON DISPOSABLE BIOPSY NEEDLE
    K900555 INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
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