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

    LITE WAND II

    K Number: K080962 · Decision Jun 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    82

    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
    LITE WAND II
    K Number
    K080962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thompson Surgical Instruments, Inc.
    Date Received
    April 4, 2008
    Decision Date
    June 25, 2008
    Product Code
    FST
    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
    FST Light, Surgical, Fiberoptic

    Similar 510(k) Clearances

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

    TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End

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

    ENDO-CORD

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

    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

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

    EIGR SURGICAL ILLUMINATION SYSTEM

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

    CABLECAP

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

    ISOLED AC-POWERED LED HEADLIGHT SYSTEM

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

    Other Clearances by Thompson Surgical Instruments, Inc.

    K Number Device Name
    K210615 Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)