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

    BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES

    K Number: K895725 · Decision Nov 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    9
    Review Days
    42

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    Basic Information

    Device Name
    BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
    K Number
    K895725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Interson Corp.
    Date Received
    September 25, 1989
    Decision Date
    November 6, 1989
    Product Code
    FCG
    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
    FCG Biopsy Needle

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    Other Clearances by Interson Corp.

    K Number Device Name
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    K911117 INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST
    K911115 INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
    K911114 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
    K911464 INTERSON DISPOSABLE BIOPSY NEEDLE
    K900555 INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
    K896680 PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.