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

    GAUZE SPONGE, NON X-RAY DETECTABLE

    K Number: K963724 · Decision Nov 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    8
    Review Days
    74

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    Basic Information

    Device Name
    GAUZE SPONGE, NON X-RAY DETECTABLE
    K Number
    K963724
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Grand Medical Products
    Date Received
    September 16, 1996
    Decision Date
    November 29, 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

    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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    GAUZE, SPONGES, CAT # 11-003

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    FDA Unclassified ·Unknown
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    Other Clearances by Grand Medical Products

    K Number Device Name
    K963715 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
    K963720 TRACHEOSTOMY KIT
    K963719 CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
    K963723 LACERATION TRAY
    K963714 GRAND MEDICAL SUTURE REMOVAL KIT
    K963721 SKIN SCRUB TRAY
    K963722 IV START KIT