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

    MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM

    K Number: K911998 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    7
    Review Days
    88

    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
    MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
    K Number
    K911998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allergan Medical Optics
    Date Received
    April 29, 1991
    Decision Date
    July 26, 1991
    Product Code
    HQE
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

    Similar 510(k) Clearances

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

    UniVit HE, UniVit UHS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Cetus system, Cetus probe

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bi-Blade Vitrectomy Cutter

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CONSTELLATION VISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VERSAVIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROCARE PLUS VITRECTOMY SYSTEM

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

    Other Clearances by Allergan Medical Optics

    K Number Device Name
    K951462 AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
    K941603 AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
    K930320 AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
    K925254 AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
    K924235 AMO ELITE
    K893199 PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR