BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MOUNTABLE ENDOSCOPIC KNIFE

    K Number: K982142 · Decision Dec 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    20
    Applicant Total
    6
    Review Days
    196

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    Basic Information

    Device Name
    MOUNTABLE ENDOSCOPIC KNIFE
    K Number
    K982142
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A.M. Surgical, Inc.
    Date Received
    June 17, 1998
    Decision Date
    December 30, 1998
    Product Code
    EMF
    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
    EMF Knife, Surgical

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