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FDA 510(k)

V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

K-Number: K093408 · 2009-11-12

ApplicantSurgical Devices, A Division of Tyco Healthcare
Decision Date2009-11-12
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, A Division of Tyco Healthcare. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K093408. 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 2009-11-12. The listed applicant is Surgical Devices, A Division of Tyco Healthcare. The 510(k) number is K093408.

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 2009-11-12, under 510(k) number K093408.

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

The FDA 510(k) record lists Surgical Devices, A Division of Tyco Healthcare 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.

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Other records listing Surgical Devices, A Division of Tyco Healthcare as applicant

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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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