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510(k) Data Aggregation

    K Number
    K060648
    Device Name
    REPROCESSED PHACOEMULSIFICATION TIPS
    Manufacturer
    ALLIANCE MEDICAL CORP.
    Date Cleared
    2007-03-19

    (371 days)

    Product Code
    NKX
    Regulation Number
    886.4670
    Why did this record match?
    Product Code :

    NKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures. Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
    Device Description
    Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.
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    K Number
    K050518
    Device Name
    REPROCESSED PHACOEMUISIFICATION TIPS
    Manufacturer
    ALLIANCE MEDICAL, INC.
    Date Cleared
    2005-09-23

    (206 days)

    Product Code
    NKX
    Regulation Number
    886.4670
    Why did this record match?
    Product Code :

    NKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures. Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
    Device Description
    Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.
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    K Number
    K030179
    Device Name
    MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
    Manufacturer
    SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
    Date Cleared
    2003-01-24

    (7 days)

    Product Code
    NKX, HQC
    Regulation Number
    886.4670
    Why did this record match?
    Product Code :

    NKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.
    Device Description
    Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip. Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only.
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    K Number
    K012698
    Device Name
    VANGUARD REPROCESSED PHACOEMULSIFICATION
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Date Cleared
    2001-11-09

    (87 days)

    Product Code
    NKX
    Regulation Number
    886.4670
    Why did this record match?
    Product Code :

    NKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As an accessory device of a compatible phacoemulsification system, the phaco needle is intended for the breaking up of a cataractous lens nucleus with simultaneous irrigation and aspiration of the emulsified fragments.
    Device Description
    A phacoemulsification needle is a component of a phacoemulsification system that utilizes ultrasound to disrupt and extract a cataract through a small incision. Ultrasonic energy combined with the mechanical action of the vibrating tip applicator (phaco tip) is applied to the cataractous lens of the eye. The lens undergoes fragmentation and emusification and is rapidly removed from the eye by aspiration. The phaco tip is a hollow titanium needle located centrally in a handpiece with is connected via an irrigation and/or aspiration line(s) to a console for powering and controlling the functions of the phaco system. The tip is piezoelectronically oscillated longitudinally at an ultrasonic frequency of about 40,000 hertz. Vanguard receives previously used phaco needles (only) from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
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    K Number
    K012579
    Device Name
    REPROCESSED PHACO TIPS
    Manufacturer
    STERILMED, INC.
    Date Cleared
    2001-11-08

    (91 days)

    Product Code
    NKX
    Regulation Number
    886.4670
    Why did this record match?
    Product Code :

    NKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
    Device Description
    The phaco tip is a component of the phacoemulsification system. The tip is attached to an ultrasonic transducer. When properly stimulated, the transducer lengthens and shortens, causing the tip to oscillate at a specific frequency usually between 27 to 64 kHz. Phacofragmentation of the cataractous lens is accomplished by the action of the phaco tip, a hollow needle located centrally in the device handpiece. When the device is used in the phacofragmentation mode both irrigation and aspiration occur simultaneously. The irrigating solution enters the eye via a collinear axial lumen, which encircles the phaco tip. The fragmentation process is the result of combined mechanical and ultrasonic action induced by the oscillating phaco tip. The cataractous lens and its fragments are disrupted by the phaco tip during the procedure and removed due to the pump suction at the phaco tip orifice. This submission is for the phaco tip only.
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