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

    4 X 4 STERILE GAUZE SPONGE TRAY

    K Number: K893902 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    7
    Review Days
    45

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    4 X 4 STERILE GAUZE SPONGE TRAY
    K Number
    K893902
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Mumtaz I. Malik
    Date Received
    May 30, 1989
    Decision Date
    July 14, 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

    FDA 510(k)
    FDA Unclassified ·Unknown

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

    FDA 510(k)
    FDA Unclassified ·Unknown

    VITOP DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

    FDA 510(k)
    FDA Unclassified ·Unknown

    CROSSTEX NON-WOVEN SPONGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Mumtaz I. Malik

    K Number Device Name
    K901521 OSTEOTOMES OF VARIOUS TYPES
    K901289 RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
    K901511 CHISEL, BONE, SURGICAL
    K901420 VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
    K890071 STERILE LACERATION TRAY
    K884195 GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)