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

    ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)

    K Number: K980022 · Decision Mar 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    111
    Review Days
    63

    Basic Information

    Device Name
    ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
    K Number
    K980022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ETHICON ENDO-SURGERY, INC.
    Date Received
    January 5, 1998
    Decision Date
    March 9, 1998
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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