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

    VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION

    K Number: K882956 · Decision Aug 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    27
    Applicant Total
    9
    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
    VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION
    K Number
    K882956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Vital Metrics, Inc.
    Date Received
    July 13, 1988
    Decision Date
    August 3, 1988
    Product Code
    HBI
    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
    HBI Illuminator, Fiberoptic, Surgical Field

    Similar 510(k) Clearances

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

    Light-Guide Cables

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

    OptiLux LED Illuminator

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

    KOGENT SPETZLER LIGHTED SUCTION TUBES

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

    LIGHT GUIDE CABLE

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

    1125 XSB XENON FIBER-OPTIC LIGHT SOURCE

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

    ENDOSCOPIC FIBEROPTIC CABLE

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

    Other Clearances by Vital Metrics, Inc.

    K Number Device Name
    K883201 VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS
    K844973 IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES
    K843441 URINARY DRAINAGE CONTAINER 2012-WITH
    K843442 URINARY DRAINAGE CONTAINER 2013 WITH
    K840917 URINARY MONITORING SYS 240
    K834448 URINARY DRAINAGE CONTAINER
    K832526 UROTRACK PLUS
    K813641 VITAL METRICS URINE MONITORING SYSTEM