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

    MICRO-AIRE OTO/NEURO DRILL SYSTEM

    K Number: K854331 · Decision Jan 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    40
    Review Days
    85

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    Basic Information

    Device Name
    MICRO-AIRE OTO/NEURO DRILL SYSTEM
    K Number
    K854331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Micro-Aire Surgical Instruments, Inc.
    Date Received
    October 28, 1985
    Decision Date
    January 21, 1986
    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 Micro-Aire Surgical Instruments, Inc.

    K Number Device Name
    K904949 A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
    K903713 OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
    K902676 MICROGUARD, ORTHOPEDIC PIN PROTECTORS
    K903650 OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
    K903664 MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
    K901967 DENDIA WERK BURS AND CUTTING DISCS
    K901735 ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
    K902168 ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
    K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
    K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
    Search all 40 clearances from Micro-Aire Surgical Instruments, Inc. →