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

    GAUZE SPONGE

    K Number: K895086 · Decision Oct 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    5
    Review Days
    76

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    Basic Information

    Device Name
    GAUZE SPONGE
    K Number
    K895086
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Keilei Intl., Inc.
    Date Received
    August 8, 1989
    Decision Date
    October 23, 1989
    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

    Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.

    NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE

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

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    VITOP DRESSING

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    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    CROSSTEX NON-WOVEN SPONGES

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    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

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    FDA Unclassified ·Unknown
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    Other Clearances by Keilei Intl., Inc.

    K Number Device Name
    K913779 BANDAGE ROLL, GAUZE
    K912779 GAUZE SPONGE,STERILE 2'S
    K913575 GAUZE PACKING, SURGICAL STERILE AND NON-STERILE
    K895372 X-RAY DETECTABLE GAUZE SPONGE