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

    MADAYAG TYPE NEEDLE

    K Number: K813462 · Decision Mar 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    9
    Review Days
    80

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    Basic Information

    Device Name
    MADAYAG TYPE NEEDLE
    K Number
    K813462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Ocean Medical Products, Ltd.
    Date Received
    December 11, 1981
    Decision Date
    March 1, 1982
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Ocean Medical Products, Ltd.

    K Number Device Name
    K882013 SOFT TISSUE BIOPSY DEVICE
    K870896 NOTCH-NEEDLE, WESCOTT STYLE
    K843719 SINGLE WALL INTRODUCER NEEDLE
    K823693 MYELOGRAPHY NEEDLE
    K823692 SPINAL NEEDLE
    K813448 POTTS-COURNAND STYLE NEEDLE
    K813460 CHIBA SKINNY NEEDLE
    K813461 PERCUTANEOUS ENTRY NEEDLE, SELDINGER