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

    HALL MICROCHOICE ELECTRIC POWERED SYSTEM

    K Number: K942660 · Decision Sep 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    8
    Review Days
    93

    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
    HALL MICROCHOICE ELECTRIC POWERED SYSTEM
    K Number
    K942660
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hall Surgical, Division of Zimmer, Inc.
    Date Received
    June 6, 1994
    Decision Date
    September 7, 1994
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

    Similar 510(k) Clearances

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

    IntelliSense Drill

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

    ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

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

    SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE

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

    EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

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

    SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

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

    REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

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

    Other Clearances by Hall Surgical, Division of Zimmer, Inc.

    K Number Device Name
    K864734 HALL ORAL IMPLANT SYSTEM
    K864929 HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
    K864163 HALL DUNBAR DRILL GUIDE SYSTEM
    K862778 HALL CANNLULA SYSTEM
    K862474 HALL STERNUM SAW
    K862529 HALL STERILE BUR
    K852143 HALL IRRIGATION SYSTEM