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510(k) Data Aggregation
K Number
K091087Device Name
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Manufacturer
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
Date Cleared
2009-04-22
(7 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The V-Loc™ 180 absorbable wound closure device is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.
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K Number
K082662Device Name
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Manufacturer
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
Date Cleared
2009-03-26
(195 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.
Device Description
The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
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