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FDA 510(k)

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture

K-Number: K181652 · 2018-09-28

ApplicantETHICON, Inc.
Decision Date2018-09-28
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K181652. 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 Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture?

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by ETHICON, Inc.. The 510(k) number is K181652.

When was Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture approved by the FDA?

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture received FDA 510(k) clearance on 2018-09-28, under approval number K181652.

What company makes Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture?

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is manufactured by ETHICON, Inc..

What is the FDA product code for Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture?

The FDA product code for Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is GAM.

Related Clinical Trials

NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

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Related Devices (Code: GAM)

K160564TroClose1200Gordian Surgical, Ltd. K161726E-Pack Procedure KitETHICON, Inc. K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing DeviceEthicon, LLC K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. K171001Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical SutureCpt Sutures Co., Ltd.

Official Source

View on FDA Database →

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

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