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

    X-VEE

    K Number: K810152 · Decision Mar 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    55

    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
    X-VEE
    K Number
    K810152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Temporaty Surgical Systems
    Date Received
    January 21, 1981
    Decision Date
    March 17, 1981
    Product Code
    HKP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered

    Similar 510(k) Clearances

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

    AARON VAC 2

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    THE GRIESHABER AXIAL CUTTER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNIVIT PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VISITEC VITRECTOMY UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MENTOR ANTERIOR SEGMENT VITRECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all