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Found 4 results
510(k) Data Aggregation
K Number
K221759Device Name
Cornisol
Manufacturer
Aurolab
Date Cleared
2022-10-05
(110 days)
Product Code
LYX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Aurolab
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CORNISOL is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).
Device Description
Cornisol is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8℃ for up to 14 days. Cornisol is for single use and to be used only by physicians or highly skilled personnel such as eye bank operators. Corneas are directly placed in Cornisol medium after surgery with a storage time based on the time needed to obtain serology results of the donor but for a period of time of no more than 14 days.
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K Number
K140039Device Name
POLYCRYL
Manufacturer
AUROLAB
Date Cleared
2014-09-15
(251 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
AUROLAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Absorbable Surgical Suture USP/EP is indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of this suture in cardiovascular, neurological and micro surgery have not been established.
Device Description
Not Found
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K Number
K024090Device Name
NYLON SUTURE
Manufacturer
AUROLAB
Date Cleared
2003-02-28
(79 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
AUROLAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aurolab nonabsorbable, synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture. The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.
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K Number
K024091Device Name
SILK SUTURES
Manufacturer
AUROLAB
Date Cleared
2003-02-28
(79 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
AUROLAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aurolab nonabsorbable Silk suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.
This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.
This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.
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