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FDA 510(k)

V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

K-Number: K082662 · 2009-03-26

ApplicantSurgical Devices, Tyco Healthcare Group LP
Decision Date2009-03-26
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Devices, Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2009-03-26 under 510(k) number K082662. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE?

V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2009-03-26. The listed applicant is Surgical Devices, Tyco Healthcare Group LP. The 510(k) number is K082662.

When did V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE receive FDA 510(k) clearance?

V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE received FDA 510(k) clearance on 2009-03-26, under 510(k) number K082662.

Who is the listed applicant for V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE?

The FDA 510(k) record lists Surgical Devices, Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE?

The FDA product code for V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE is GAM.

Related Clinical Trials

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Other records listing Surgical Devices, Tyco Healthcare Group LP as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091087MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

Related Devices (Code: GAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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