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

    GAUZE SPONGE

    K Number: K884826 · Decision Dec 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    GAUZE SPONGE
    K Number
    K884826
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Medical Action Industries, Inc.
    Date Received
    November 18, 1988
    Decision Date
    December 22, 1988
    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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    FDA Unclassified ·Unknown

    VITOP DRESSING

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    FDA Unclassified ·Unknown

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    FDA Unclassified ·Unknown

    CROSSTEX NON-WOVEN SPONGES

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    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

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    FDA Unclassified ·Unknown
    View all

    Other Clearances by Medical Action Industries, Inc.

    K Number Device Name
    K042526 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
    K042527 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    K022948 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    K946019 SURGICLA INSTRUMENT KIT
    K923846 BURN DRESSING
    K810685 SUTURE REMOVAL KIT
    K810184 LAPAROTOMY SPONGE