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510(k) Data Aggregation
K Number
K100257Device Name
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
Manufacturer
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
Date Cleared
2010-05-10
(102 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
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K Number
K100242Device Name
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
Manufacturer
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
Date Cleared
2010-02-17
(21 days)
Product Code
FZP, GDO
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.
Device Description
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
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K Number
K093408Device Name
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
Manufacturer
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
Date Cleared
2009-11-12
(10 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
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 (Size 4-0) 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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