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

    MEDNEXT MICRO-DRILL

    K Number: K943108 · Decision Aug 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    7
    Review Days
    49

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    Basic Information

    Device Name
    MEDNEXT MICRO-DRILL
    K Number
    K943108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mednext, Inc.
    Date Received
    June 29, 1994
    Decision Date
    August 17, 1994
    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 Mednext, Inc.

    K Number Device Name
    K983092 TRITON HUDSON CHUCK ATTACHMENT
    K972308 MEDNEXT 1000 DRILL
    K970023 MEDNEXT SURGICAL BUR
    K935861 MEDNEXT BUR
    K935584 MEDNEXT BUR
    K926547 MEDNEXT 1000 BONE DISSECTING SYSTEM