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

    HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO

    K Number: K911341 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    9
    Review Days
    90

    Basic Information

    Device Name
    HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO
    K Number
    K911341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    ULTRACISION, INC.
    Date Received
    March 26, 1991
    Decision Date
    June 24, 1991
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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