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

    MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL

    K Number: K962163 · Decision Jul 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    4
    Review Days
    51

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    Basic Information

    Device Name
    MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
    K Number
    K962163
    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
    Misten Medical Corp.
    Date Received
    June 4, 1996
    Decision Date
    July 25, 1996
    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 Misten Medical Corp.

    K Number Device Name
    K955616 MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
    K955613 MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
    K955615 MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS