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510(k) Data Aggregation

    K Number
    K081382
    Device Name
    DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2008-10-23

    (160 days)

    Product Code
    KYB
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DUCKWORTH **& KENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DK7786 handpiece is used in combination with the One Series™ Ultra Cartridge to fold and assist in inserting TECNIS® 1-Piece intraocular lenses. ONLY into the capsular bag.
    Device Description
    Duckworth & Kent Ltd Model DK7786 Injector
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    K Number
    K072985
    Device Name
    DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2008-06-20

    (241 days)

    Product Code
    KYB
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DUCKWORTH **& KENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K060995
    Device Name
    DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2006-05-22

    (41 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DUCKWORTH **& KENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.
    Device Description
    Not Found
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    K Number
    K053176
    Device Name
    DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2006-01-30

    (77 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DUCKWORTH **& KENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To fold and deliver ALCON® qualified ACRYSOF® Acrylic foldable intraocular lenses into the eye for replacement of the human crystalline lens.
    Device Description
    Not Found
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    K Number
    K042478
    Device Name
    CAPSULE TENSION RING INSERTER, MODEL 7-810
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2004-12-28

    (106 days)

    Product Code
    NCE
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DUCKWORTH **& KENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure. This injector will facilitate the insertion and proper placement of the ring in the capsular bag.
    Device Description
    Not Found
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    K Number
    K024072
    Device Name
    DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2003-10-06

    (300 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DUCKWORTH **& KENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Folding and injection of Chiron Softex LI61U lens implant into the eye using a Chiron Microsert IC-5BU disposable cartridge.
    Device Description
    Not Found
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