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

    MEDNEXT BUR

    K Number: K935861 · Decision May 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    7
    Review Days
    151

    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
    MEDNEXT BUR
    K Number
    K935861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mednext, Inc.
    Date Received
    December 3, 1993
    Decision Date
    May 3, 1994
    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 Mednext, Inc.

    K Number Device Name
    K983092 TRITON HUDSON CHUCK ATTACHMENT
    K972308 MEDNEXT 1000 DRILL
    K970023 MEDNEXT SURGICAL BUR
    K943108 MEDNEXT MICRO-DRILL
    K935584 MEDNEXT BUR
    K926547 MEDNEXT 1000 BONE DISSECTING SYSTEM