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    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)

    K Number: K961061 · Decision Jun 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
    K Number
    K961061
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Codi International BV
    Date Received
    March 18, 1996
    Decision Date
    June 6, 1996
    Product Code
    EFQ
    Advisory Committee
    Unknown
    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
    EFQ Gauze/Sponge, Internal

    Similar 510(k) Clearances

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    SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

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    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    GAUZE, SPONGES, CAT # 11-003

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    Other Clearances by Codi International BV

    K Number Device Name
    K963188 DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)