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

    ROCKET BONE MARROW NEEDLE

    K Number: K895551 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    23
    Review Days
    23

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ROCKET BONE MARROW NEEDLE
    K Number
    K895551
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    A & A Medical, Inc.
    Date Received
    September 13, 1989
    Decision Date
    October 6, 1989
    Product Code
    GDM
    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
    GDM Needle, Aspiration And Injection, Reusable

    Similar 510(k) Clearances

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

    MARROWMINER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIOACCESS MARROW HARVEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ILIAC CREST BONE MARROW ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIOACCESS MARROW HARVEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ENDO-NEEDLE INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by A & A Medical, Inc.

    K Number Device Name
    K013437 SF SH CATHETER, MODEL R65-945
    K013491 HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
    K003949 TACKER, MODEL R65-933
    K011512 MMODIFICATION TO LAMINARIA
    K010510 BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
    K010789 CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
    K010056 UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
    K000027 INSUFFLATION NEEDLE, MODEL R65-933
    K994256 SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
    K974038 THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
    Search all 23 clearances from A & A Medical, Inc. →