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

    ENDO-JUDGE

    K Number: K932591 · Decision Dec 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    122
    Registration Numbers
    122
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    208

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    Basic Information

    Device Name
    ENDO-JUDGE
    K Number
    K932591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synergistic Medical Technologies, Inc.
    Date Received
    May 28, 1993
    Decision Date
    December 22, 1993
    Product Code
    GAB
    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
    GAB Needle, Suturing, Disposable

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