BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786

    K Number: K081382 · Decision Oct 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    160

    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
    DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
    K Number
    K081382
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Duckworth & Kent, Ltd.
    Date Received
    May 16, 2008
    Decision Date
    October 23, 2008
    Product Code
    KYB
    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
    KYB Lens, Guide, Intraocular

    Similar 510(k) Clearances

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

    MicroSTAAR Injector System Cartridges

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IOL INJECTOR SET

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MONARCH III IOL DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RE-USEABLE MICROSTAAR INJECTOR, MSI-S

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Duckworth & Kent, Ltd.

    K Number Device Name
    K072985 DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
    K060995 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
    K053176 DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
    K042478 CAPSULE TENSION RING INSERTER, MODEL 7-810
    K024072 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM