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

    ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES

    K Number: K865095 · Decision Jan 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    2
    Review Days
    21

    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
    ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES
    K Number
    K865095
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Kor-Medical Industries, Ltd.
    Date Received
    December 30, 1986
    Decision Date
    January 20, 1987
    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 Kor-Medical Industries, Ltd.

    K Number Device Name
    K865097 AIMED GAUZE SPONGE