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

    NON-WOVEN SPONGE

    K Number: K940901 · Decision Mar 31, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    4
    Review Days
    35

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    Basic Information

    Device Name
    NON-WOVEN SPONGE
    K Number
    K940901
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Insights, Inc.
    Date Received
    February 24, 1994
    Decision Date
    March 31, 1994
    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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    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 Medical Insights, Inc.

    K Number Device Name
    K940904 KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD
    K940903 TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
    K924958 BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY