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510(k) Data Aggregation
K Number
K041511Device Name
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
Manufacturer
SUTURES INDIA PRIVATE LIMITED
Date Cleared
2005-06-03
(361 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRULENE™ Non-absorbable Polypropylene Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.
The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.
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K Number
K041514Device Name
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
Manufacturer
SUTURES INDIA PRIVATE LIMITED
Date Cleared
2005-06-03
(361 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.
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K Number
K041510Device Name
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
Manufacturer
SUTURES INDIA PRIVATE LIMITED
Date Cleared
2005-06-02
(360 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible monofilament thread composed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. The suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture. The suture may be dyed Logwood Extract, C.175290 conforming to 21 CFR 73.1410. The suture may be provided with or without a standard needle attached.
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K Number
K041512Device Name
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
Manufacturer
SUTURES INDIA PRIVATE LIMITED
Date Cleared
2005-06-02
(360 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
"TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia "Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
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K Number
K041515Device Name
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
Manufacturer
SUTURES INDIA PRIVATE LIMITED
Date Cleared
2005-04-08
(305 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures
Device Description
Absorbable Surgical Suture,Synthetic (Polyglycolic Acid)
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