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

    CRANIOTOME BLADE OR DRILL BIT

    K Number: K902703 · Decision Nov 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    146

    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
    CRANIOTOME BLADE OR DRILL BIT
    K Number
    K902703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    A. Henniss
    Date Received
    June 20, 1990
    Decision Date
    November 13, 1990
    Product Code
    HBE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

    Similar 510(k) Clearances

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

    Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Hubly Drill (H100)

    FDA 510(k)
    FDA Class 2 ·Neurology

    GREEN

    FDA 510(k)
    FDA Class 2 ·Neurology

    UniBur

    FDA 510(k)
    FDA Class 2 ·Neurology

    Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by A. Henniss

    K Number Device Name
    K905445 ADSON-BECKMAN RETRACTOR, SPINAL
    K902567 STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES