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

    KUT-SHIELD

    K Number: K895092 · Decision Sep 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    43

    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
    KUT-SHIELD
    K Number
    K895092
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Kut-Guard, Inc.
    Date Received
    August 14, 1989
    Decision Date
    September 26, 1989
    Product Code
    FYH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FYH Splint, Extremity, Noninflatable, External, Sterile

    Similar 510(k) Clearances

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

    TRACE MODEL #'S 840, 841, 842, 845

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

    SPECIALIST(R) WALKER

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

    SPLINTS(ALL TYPE)

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

    HYDRO-SPLINT A SPONGE-COMPRESS DRESS

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

    J & J DIP WATER ADDITIVE

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

    DELTA-LITE CASTING TAPE & SPLINTS

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

    Other Clearances by Kut-Guard, Inc.

    K Number Device Name
    K895884 BANDAGE REMOVAL STRIP