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510(k) Data Aggregation

    K Number
    K132796
    Device Name
    SUNTOUCH EYE SPEAR
    Manufacturer
    HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
    Date Cleared
    2013-10-30

    (54 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
    Device Description
    SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
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    K Number
    K130117
    Device Name
    NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
    Manufacturer
    NETWORK MEDICAL PRODUCTS, LTD.
    Date Cleared
    2013-10-29

    (286 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Network Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field. Network Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field. Network Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.
    Device Description
    Network Eve Spears, Points, Drains, Wicks and Shields are single devices designed for tissue manipulation, fluid management and shielding of light in ophthalmic surgery. Spears and points consist of a triangle of dry Polyvinyl Alcohol (formalized) Sponge (PVA) or Cellulose sponge, either attached to a polypropylene handle for handling or separate to be picked up by forceps. The triangular shape allows the surgeon to carry out pinpoint absorption of liguid. Drains and Wicks are PVA Sponges in various sizes and shapes for wicking of fluid away from the operative field. Shields are circular-shaped PVA Sponges that moisten the cornea and reduce the light intensity on the retina during surgery.
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    K Number
    K091240
    Device Name
    ALPHAMED SURGICAL SPEAR, MODEL 70-5000
    Manufacturer
    ALPHAMED INC.
    Date Cleared
    2009-10-23

    (179 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery
    Device Description
    Not Found
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    K Number
    K082460
    Device Name
    CENEFOM PVA SURGICAL SPEAR
    Manufacturer
    LONGTEK SCIENTIFIC CO., LTD.
    Date Cleared
    2008-12-15

    (111 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cenefom PVA Surgical Spear is indicated for short-term transient use in ophthalmic surgical procedures for absorbing excess fluids from the operative field.
    Device Description
    Not Found
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    K Number
    K012196
    Device Name
    ULTRACELL ABSORBENT STICK
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-08-24

    (42 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate.
    Device Description
    Not Found
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    K Number
    K982599
    Device Name
    THE FREMSTAD RING
    Manufacturer
    OPHTHALMIC SOLUTIONS, LLC.
    Date Cleared
    1999-02-16

    (204 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea.
    Device Description
    The Ophthalmic Solutions, LLC, The Fremstad Ring™ is used as a sponge. The device material consists of cellulosic and synthetic fibers. 14mm diameter, round, inner diameter 11mm, thickness 0.1 mm.
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    K Number
    K980696
    Device Name
    FOAM TIP INJECTOR
    Manufacturer
    STAAR SURGICAL CO.
    Date Cleared
    1998-09-11

    (200 days)

    Product Code
    MSS
    Regulation Number
    886.4300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.
    Device Description
    STAAR Surgical Company's Foam Tip™ Injector is used to fold and insert STAAR Surgical UV-ELASTIC™ silicone intraocular lenses for surgical placement into the human eye. The new Foam Tip™ Injector utilizes the same design principles (i.e. a plunger pushing or threaded mechanism) to push the IOL through a cartridge for injection into the eye as the existing MicroSTAART™ injectors. The new injector system differs from the MicroSTAART™ injector in that it contains a disposable Foam Tip™ plunger insert which may be attached to the sterilized injector body prior to lens loading. This attachable Foam Tip™ plunger insert is encapsulated inside a holder that protects the sponge from damage. The holder acts to guide the plunger as it slides into the injector body and performs as a wrench to remove the plunger from the injector once the lens has been implanted. Once the sponge portion of the foam plunger insert is hydrated, it enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.
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    K Number
    K971832
    Device Name
    IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
    Manufacturer
    M-PACT WORLDWIDE MANAGEMENT CORP.
    Date Cleared
    1997-07-31

    (73 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.
    Device Description
    The Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are packaged individually as a sterile, dried and compressed sponge. They are used to absorb fluids from the operative field in ophthalmic surgery. M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde.
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