BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOFT TISSUE BIOPSY DEVICE

    K Number: K882013 · Decision Jun 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    33

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    Basic Information

    Device Name
    SOFT TISSUE BIOPSY DEVICE
    K Number
    K882013
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Ocean Medical Products, Ltd.
    Date Received
    May 13, 1988
    Decision Date
    June 15, 1988
    Product Code
    DWO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWO Needle, Biopsy, Cardiovascular

    Similar 510(k) Clearances

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    MEDSURG GREENE NEEDLE

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    NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE

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    Other Clearances by Ocean Medical Products, Ltd.

    K Number Device Name
    K870896 NOTCH-NEEDLE, WESCOTT STYLE
    K843719 SINGLE WALL INTRODUCER NEEDLE
    K823693 MYELOGRAPHY NEEDLE
    K823692 SPINAL NEEDLE
    K813462 MADAYAG TYPE NEEDLE
    K813448 POTTS-COURNAND STYLE NEEDLE
    K813460 CHIBA SKINNY NEEDLE
    K813461 PERCUTANEOUS ENTRY NEEDLE, SELDINGER