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510(k) Data Aggregation
K Number
K142810Device Name
WEGO-PGCL Absorbable Surgical Monofilament Suture
Manufacturer
FOOSIN MEDICAL SUPPLIES INC.LTD
Date Cleared
2014-11-14
(46 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
FOOSIN MEDICAL SUPPLIES INC.LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
Device Description
The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery.
The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL); and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture.
The proposed suture is available in 6-0, 5-0, 4-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35<861>, USP 35<871> and USP35 <881>.
The Synthetic Absorbable Suture is provided EO sterilized as a single used device.
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K Number
K130735Device Name
SYNTHETIC ABSORBABLE SUTURE
Manufacturer
FOOSIN MEDICAL SUPPLIES INC.LTD
Date Cleared
2014-01-14
(302 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
FOOSIN MEDICAL SUPPLIES INC.LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WEGO-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
Device Description
The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. It is composed of PGLA suture and needle. The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture is available in 6-0, 5-0, 4-0, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia. The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
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K Number
K130737Device Name
SYNTHETIC ABSORBABLE SUTURE
Manufacturer
FOOSIN MEDICAL SUPPLIES INC.LTD
Date Cleared
2014-01-14
(302 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
FOOSIN MEDICAL SUPPLIES INC.LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
Device Description
The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery. The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL): and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture size is 3-0, which is the size identified in the currently recognized United States Pharmacopoeia. The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35<861>, USP 35<871> and USP35 <881>. The Synthetic Absorbable Suture is provided EO sterilized as a single used device.
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