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510(k) Data Aggregation
K Number
K102592Device Name
SUTRAZORB
Manufacturer
VISIONARY MEDICAL SUPPLIES, INC.
Date Cleared
2011-02-03
(147 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
VISIONARY MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.
Device Description
The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0.
The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0:
- Sutures - Diameter <861>
- Sutures Needle Attachment <871>
- Tensile Strength <881>
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K Number
K070243Device Name
SUTRALENE POLYPROPYLENE SUTURES
Manufacturer
VISIONARY MEDICAL SUPPLIES, INC.
Date Cleared
2007-04-17
(82 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
VISIONARY MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
Device Description
This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.
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K Number
K994176Device Name
SUTRALON NYLON SUTURES
Manufacturer
VISIONARY MEDICAL SUPPLIES, INC.
Date Cleared
2000-02-08
(60 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
VISIONARY MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sutralon 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 non-absorbable 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 a 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 The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.
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K Number
K994177Device Name
SUTRASILK SILK SUTURE
Manufacturer
VISIONARY MEDICAL SUPPLIES, INC.
Date Cleared
2000-02-08
(60 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
VISIONARY MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SutraSilk nonabsorbable silk sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
SutraSilk silk suture is a nonabsorbable, sterile, surgical suture 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 non-absorbable suture is composed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specifications.
The suture may be uncoated or have a silicone coating, a paraffin wax coating, or a natural gum coating (Virgin silk). The sutures come with needles attached.
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