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

    MICRO-SURGICAL POWER INSTRUMENT SYSTEM

    K Number: K802463 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    MICRO-SURGICAL POWER INSTRUMENT SYSTEM
    K Number
    K802463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Spire Medical, Inc.
    Date Received
    October 9, 1980
    Decision Date
    October 31, 1980
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    Other Clearances by Spire Medical, Inc.

    K Number Device Name
    K821487 MICRO-SURGICAL POWER INSTRUMENT SYS.
    K821485 DERMABRADERS
    K821486 MICRO DRILLS
    K802503 MICRO-SUGICAL POWER INSTRUMENT SYSTEM