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

    PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750

    K Number: K992091 · Decision Sep 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    466
    Registration Numbers
    466
    Same Product Code
    680
    Applicant Total
    6
    Review Days
    80

    Basic Information

    Device Name
    PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
    K Number
    K992091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIO-PLEXUS, INC.
    Date Received
    June 21, 1999
    Decision Date
    September 9, 1999
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.

    K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FROG (Filter Removal of Glass)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SureFine Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Safety Winged Blood Collection Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by BIO-PLEXUS, INC.

    K Number Device Name
    K003827 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
    K963748 BIO-PLEXUS DROP-IT NEEDLE HOLDER
    K960933 BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
    K961251 PUNCTUR-GUARD WINGED SET
    K895024 PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE