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 Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

K-Number: K253852 · 2026-02-06

ApplicantETHICON, Inc.
Decision Date2026-02-06
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2026-02-06 under approval number K253852. 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 Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture?

MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by ETHICON, Inc.. The 510(k) number is K253852.

When was MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture approved by the FDA?

MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture received FDA 510(k) clearance on 2026-02-06, under approval number K253852.

What company makes MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture?

MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is manufactured by ETHICON, Inc..

What is the FDA product code for MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture?

The FDA product code for MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is GAM.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05538286 Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation RECRUITING

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.

↑