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

    PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE

    K Number: K895024 · Decision Sep 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    6
    Review Days
    409

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    Basic Information

    Device Name
    PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE
    K Number
    K895024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Bio-Plexus, Inc.
    Date Received
    August 8, 1989
    Decision Date
    September 21, 1990
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Bio-Plexus, Inc.

    K Number Device Name
    K003827 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
    K992091 PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
    K963748 BIO-PLEXUS DROP-IT NEEDLE HOLDER
    K960933 BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
    K961251 PUNCTUR-GUARD WINGED SET