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FDA 510(k)

VLOC9ABSORBABLE WOUND CLOSURE DEVICE

K-Number: K100257 · 2010-05-10

ApplicantSurgical Devices, A Division of Tyco Healthcare
Decision Date2010-05-10
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VLOC9ABSORBABLE 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 2010-05-10 under 510(k) number K100257. 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 VLOC9ABSORBABLE WOUND CLOSURE DEVICE?

VLOC9ABSORBABLE WOUND CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Surgical Devices, A Division of Tyco Healthcare. The 510(k) number is K100257.

When did VLOC9ABSORBABLE WOUND CLOSURE DEVICE receive FDA 510(k) clearance?

VLOC9ABSORBABLE WOUND CLOSURE DEVICE received FDA 510(k) clearance on 2010-05-10, under 510(k) number K100257.

Who is the listed applicant for VLOC9ABSORBABLE 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 VLOC9ABSORBABLE WOUND CLOSURE DEVICE?

The FDA product code for VLOC9ABSORBABLE WOUND CLOSURE DEVICE is GAM.

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Other records listing Surgical Devices, A Division of Tyco Healthcare 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.

K100242AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTERK093408V-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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