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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
    Why did this record match?
    Product Code :

    HOZ

    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
    Why did this record match?
    Product Code :

    HOZ

    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
    Why did this record match?
    Product Code :

    HOZ

    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
    Why did this record match?
    Product Code :

    HOZ

    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
    Why did this record match?
    Product Code :

    HOZ

    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
    K011191
    Device Name
    MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
    Manufacturer
    MEDTRONIC XOMED, INC.
    Date Cleared
    2001-06-26

    (68 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Product Code :

    HOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003842
    Device Name
    PRESCOTT'S SURGICAL SPEAR
    Manufacturer
    PRESCOTT'S, INC.
    Date Cleared
    2001-04-13

    (122 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Product Code :

    HOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002279
    Device Name
    ML EYE SPEAR, MODEL ML 27 ES
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2000-08-18

    (23 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Product Code :

    HOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993883
    Device Name
    M-PACT CORNEAL LIGHT SHIELD
    Manufacturer
    M-PACT CORP.
    Date Cleared
    1999-12-21

    (36 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Product Code :

    HOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.
    Device Description
    The M-Pact Corneal Light Shield is designed to be placed on the surface of the cornea during ophthalmic procedures to shield the retina from excessive illumination. The Corneal Light Shield is transient to minimal short-term use only. The Shield is nonabrasive, and is formulated to resist tearing or shedding of fibers.
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    K Number
    K990671
    Device Name
    DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
    Manufacturer
    HURRICANE MEDICAL
    Date Cleared
    1999-05-10

    (69 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Product Code :

    HOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.
    Device Description
    Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron. Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge. Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery. Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton. Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.
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