BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    X-RAY DETECTABLE GAUZE SPONGE

    K Number: K895372 · Decision Nov 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    5
    Review Days
    66

    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
    X-RAY DETECTABLE GAUZE SPONGE
    K Number
    K895372
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Keilei Intl., Inc.
    Date Received
    August 29, 1989
    Decision Date
    November 3, 1989
    Product Code
    GDY
    Advisory Committee
    General, Plastic Surgery
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

    Similar 510(k) Clearances

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

    ULTRACELL SUCTION SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CPR LAP SPONGES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PROTEC X-RAY DETECTABLE GAUZE SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KENSORB

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TRIANGULAR SPONGES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    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
    K895086 GAUZE SPONGE