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510(k) Data Aggregation

    K Number
    K980100
    Device Name
    STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1998-06-01

    (140 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.
    Device Description
    The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction. The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.
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    K Number
    K980488
    Device Name
    STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1998-03-23

    (42 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.
    Device Description
    The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack.
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    K Number
    K972664
    Device Name
    STORZ MILLENNIUM VISCOUS FLUID SYSTEM
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1997-10-10

    (86 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments.
    Device Description
    The Storz Millennium™ Viscous Fluid System is intended for the injection and aspiration of viscous fluids into and out of the eye during posterior ophthalmic vitreoretinal surgery. The system is designed to inject and aspirate viscous fluids, such as silicone oil which act as a tamponade in fixating large retinal tears and detachments. The Storz viscous fluid system consists of the Storz CX5700 Millennium™ Viscous Fluid System Module and the Storz CX5710 Viscous Fluid Injection Pack. The Storz CX5700 module is a self-contained pump system used as an individual module with the Storz Millennium™ Microsurgical System for the injection and aspiration of viscous fluids. The Storz CX5710 is the disposable accessory pack intended for single use to be used with the Storz viscous fluid module.
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    K Number
    K971439
    Device Name
    STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1997-06-17

    (60 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.
    Device Description
    A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens. Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.
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    K Number
    K964743
    Device Name
    STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1997-02-03

    (69 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTecTM Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.
    Device Description
    The Storz E8010 ErgoTec™/Premiere® Adaptor is composed of stainless steel and serves to allow connection of the existing Storz D7108 Microscissors Handpiece to the existing Storz ErgoTecTM Vitreoretinal Instrument Tips. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.
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    K Number
    K960024
    Device Name
    STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1996-09-20

    (262 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
    Device Description
    The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
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    K Number
    K960061
    Device Name
    STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1996-09-18

    (258 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.
    Device Description
    The Storz D7108 Microscissors Handpiece is a reusable, electrically powered, pneumatic handpiece that is used to operate a variety of detachable microscissors. A selected microscissors attachment screws on to the tip of the D7108 Microscissors Handpiece The D7108 handpiece attaches to the Storz D7106 Microscissors Drive Tube, which in turn connects to the Storz PREMIERE® or the Storz DAISY™ Ophthalmic Microsurgical System. As the "Scissors" function of the microsurgical system is activated, the piston inside the D7108 handpiece is driven forward and backward by air pressure, causing the blades of the attached microscissors to open and close rapidly. The handpiece also has a manual over-ride lever near the tip of the handpiece that allows the physician to manually operate the scissors without requiring external power.
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    K Number
    K960003
    Device Name
    STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1996-08-29

    (240 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument.
    Device Description
    The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument. The D7116 does not affect the functioning of the cutter.
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    K Number
    K962131
    Device Name
    STORZ D4600 AIR EXCHANGE LINE PACK
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1996-08-23

    (81 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
    Device Description
    The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
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    K Number
    K961831
    Device Name
    STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1996-08-06

    (85 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    STORZ INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
    Device Description
    The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
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