Search Results
Found 8 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?
Search-Everything :
Matched: '886.4790'
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.
Ask a Question
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?
Search-Everything :
Matched: '886.4790'
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.
Ask a Question
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?
Search-Everything :
Matched: '886.4790'
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
Ask a Question
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?
Search-Everything :
Matched: '886.4790'
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
Ask a Question
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?
Search-Everything :
Matched: '886.4790'
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
Ask a Question
K Number
K982599Device Name
THE FREMSTAD RING
Manufacturer
OPHTHALMIC SOLUTIONS, LLC.
Date Cleared
1999-02-16
(204 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Search-Everything :
Matched: '886.4790'
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.
Ask a Question
K Number
K980696Device Name
FOAM TIP INJECTOR
Manufacturer
STAAR SURGICAL CO.
Date Cleared
1998-09-11
(200 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Search-Everything :
Matched: '886.4790'
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.
Ask a Question
K Number
K971832Device 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
886.4790Why did this record match?
Search-Everything :
Matched: '886.4790'
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.
Ask a Question
Page 1 of 1