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Found 6 results
510(k) Data Aggregation
K Number
K140352Device Name
VERAPLUG
Manufacturer
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
Date Cleared
2014-11-13
(274 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
Device Description
The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.
The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
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K Number
K022835Device Name
STEPHENS DISPOSABLE FORCEPS
Manufacturer
STEPHENS INSTRUMENTS
Date Cleared
2002-11-01
(66 days)
Product Code
HNR
Regulation Number
886.4350Why did this record match?
Applicant Name (Manufacturer) :
STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.
Device Description
A single use ophthalmic device designed to manipulate eye tissues or muscles.
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K Number
K022836Device Name
STEPHENS DISPOSABLE SPECULUM
Manufacturer
STEPHENS INSTRUMENTS
Date Cleared
2002-11-01
(66 days)
Product Code
HNC
Regulation Number
886.4350Why did this record match?
Applicant Name (Manufacturer) :
STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
Device Description
A single use ophthalmic device designed to retract the eyelids.
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K Number
K022840Device Name
STEPHENS DISPOSABLE SCISSORS
Manufacturer
STEPHENS INSTRUMENTS
Date Cleared
2002-11-01
(66 days)
Product Code
HNF
Regulation Number
886.4350Why did this record match?
Applicant Name (Manufacturer) :
STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scissors made for single use in the cutting of tissue in various ophthalmic procedures.
Device Description
A single use ophthalmic device designed for cutting tissues.
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K Number
K022842Device Name
STEPHENS DISPOSABLE HOOKS
Manufacturer
STEPHENS INSTRUMENTS
Date Cleared
2002-11-01
(66 days)
Product Code
HNQ
Regulation Number
886.4350Why did this record match?
Applicant Name (Manufacturer) :
STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.
Device Description
A single use ophthalmic device designed to retract eye muscles.
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K Number
K022843Device Name
GAYHEART CORNEAL EXCISION DEVICE
Manufacturer
STEPHENS INSTRUMENTS
Date Cleared
2002-11-01
(66 days)
Product Code
HRH
Regulation Number
886.4350Why did this record match?
Applicant Name (Manufacturer) :
STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trephine made for single use and for the extraction of the cornea.
Device Description
A single use ophthalmic device designed to extract the cornea.
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