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

    LAPAROTOMY SPONGE

    K Number: K822623 · Decision Oct 13, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    8
    Review Days
    44

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    Basic Information

    Device Name
    LAPAROTOMY SPONGE
    K Number
    K822623
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hermitage Hospital Products, Inc.
    Date Received
    August 30, 1982
    Decision Date
    October 13, 1982
    Product Code
    GDY
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by Hermitage Hospital Products, Inc.

    K Number Device Name
    K941802 OR TOWEL
    K923115 CLINISORB
    K923116 COMBINE II WETPROOF PAD
    K891324 HERMITEX SPONGE
    K863737 SPONGES STERILE TWIN PAKT AND SINGLES
    K843788 CUSTOM BURN DRESSING KIT
    K822987 DRESSING SPONGE