BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4

    K Number: K904965 · Decision Jan 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    72

    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
    SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
    K Number
    K904965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew Equipment Group
    Date Received
    November 5, 1990
    Decision Date
    January 16, 1991
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

    Similar 510(k) Clearances

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

    Leo Minor

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CLAVEGUARD FREEDOM SURGICAL LIGHT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MI-750 PROCEDURAL/MINOR SURGICAL LIGHT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ZF 720

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MACH LED 2SC

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Smith & Nephew Equipment Group

    K Number Device Name
    K910783 SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M