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

    INTERSON DISPOSABLE BIOPSY NEEDLE

    K Number: K911464 · Decision Sep 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    9
    Review Days
    177

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    Basic Information

    Device Name
    INTERSON DISPOSABLE BIOPSY NEEDLE
    K Number
    K911464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Interson Corp.
    Date Received
    April 3, 1991
    Decision Date
    September 27, 1991
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Interson Corp.

    K Number Device Name
    K911116 INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST
    K911113 INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST
    K911117 INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST
    K911115 INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
    K911114 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
    K900555 INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
    K896680 PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
    K895725 BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES