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

    ENDOPATH

    K Number: K942450 · Decision Aug 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    23
    Applicant Total
    111
    Review Days
    74

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    Basic Information

    Device Name
    ENDOPATH
    K Number
    K942450
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    May 23, 1994
    Decision Date
    August 5, 1994
    Product Code
    GBZ
    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
    GBZ Catheter, Cholangiography

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    K102632 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
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