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

    GORSK SPONGE CONTAINMENT SYSTEM

    K Number: K873555 · Decision Oct 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    GORSK SPONGE CONTAINMENT SYSTEM
    K Number
    K873555
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gorsk, Inc.
    Date Received
    August 28, 1987
    Decision Date
    October 23, 1987
    Product Code
    LWH
    Advisory Committee
    General Hospital
    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
    LWH Counter, Sponge, Surgical

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    Other Clearances by Gorsk, Inc.

    K Number Device Name
    K873554 GORSK INSTRUMENT REST