Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Monocryl Plus Antibacterial Suture

K-Number: K201996 · 2020-12-21

ApplicantETHICON, Inc.
Decision Date2020-12-21
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monocryl Plus Antibacterial Suture is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2020-12-21 under approval number K201996. 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 Monocryl Plus Antibacterial Suture?

Monocryl Plus Antibacterial Suture is a medical device that received FDA 510(k) clearance on 2020-12-21. It is manufactured by ETHICON, Inc.. The 510(k) number is K201996.

When was Monocryl Plus Antibacterial Suture approved by the FDA?

Monocryl Plus Antibacterial Suture received FDA 510(k) clearance on 2020-12-21, under approval number K201996.

What company makes Monocryl Plus Antibacterial Suture?

Monocryl Plus Antibacterial Suture is manufactured by ETHICON, Inc..

What is the FDA product code for Monocryl Plus Antibacterial Suture?

The FDA product code for Monocryl Plus Antibacterial Suture is GAM.

Other Devices by ETHICON, Inc.

K161726E-Pack Procedure Kit K170767Surgical Stainless Steel Suture, Stainless Steel Suture K172089PROLENE Soft Polypropylene Mesh K163152PROLENE Soft Polypropylene Mesh K181652Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

View all 30 devices →

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.

↑