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510(k) Data Aggregation

    K Number
    K993361
    Device Name
    TUBING EXTENSION SET
    Manufacturer
    HURRICANE MEDICAL
    Date Cleared
    2000-01-04

    (90 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
    Device Description
    The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
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    K Number
    K983448
    Device Name
    ML UNIVERSAL TUBING
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1998-12-18

    (79 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.
    Device Description
    Med-Logics, Inc., Administration Set (UT 3004) Med-Logics, Inc., Drainage Bag (UT 3002) Med-Logics, Inc., Universal Tubing Set (UT 3000)
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    K Number
    K980849
    Device Name
    SURGIN KIT
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    1998-07-09

    (154 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
    Device Description
    Not Found
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    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?
    Product Code :

    MSR

    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
    K972522
    Device Name
    ML-DISPOSABLE PAK
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1997-09-30

    (85 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cataract surgery to irrigate and aspirate cataract material.
    Device Description
    Not Found
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