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Found 17 results
510(k) Data Aggregation
K Number
K132796Device Name
SUNTOUCH EYE SPEAR
Manufacturer
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
Date Cleared
2013-10-30
(54 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K130117Device 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
886.4790Why 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
K091240Device Name
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
Manufacturer
ALPHAMED INC.
Date Cleared
2009-10-23
(179 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K082460Device Name
CENEFOM PVA SURGICAL SPEAR
Manufacturer
LONGTEK SCIENTIFIC CO., LTD.
Date Cleared
2008-12-15
(111 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K012196Device Name
ULTRACELL ABSORBENT STICK
Manufacturer
ULTRACELL MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-08-24
(42 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K011191Device 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
886.4790Why 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
K003842Device Name
PRESCOTT'S SURGICAL SPEAR
Manufacturer
PRESCOTT'S, INC.
Date Cleared
2001-04-13
(122 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K002279Device Name
ML EYE SPEAR, MODEL ML 27 ES
Manufacturer
MED-LOGICS, INC.
Date Cleared
2000-08-18
(23 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K993883Device Name
M-PACT CORNEAL LIGHT SHIELD
Manufacturer
M-PACT CORP.
Date Cleared
1999-12-21
(36 days)
Product Code
HOZ
Regulation Number
886.4790Why 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
K990671Device 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
886.4790Why 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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