FDA 510(k)

Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture

K-Number: K253394 · 2026-06-25

Decision Date2026-06-25

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253394. 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™ (Polyglactin 910) Plus Antibacterial Suture?

Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is ETHICON, Inc.. The 510(k) number is K253394.

When did Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture receive FDA 510(k) clearance?

Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253394.

Who is the listed applicant for Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

NCT04829058GYNEMESH PS Mesh Post Marketing Clinical Follow-Up StudyRECRUITING NCT04829175Ethicon Pelvic Mesh Post Market Clinical Follow-up RegistryRECRUITING NCT04829357Post Market Clinical Follow-up Study on TVT ABBREVO® Continence SystemRECRUITING NCT04829994Post-Market Clinical Follow-Up onTVT EXACT® Continence SystemACTIVE_NOT_RECRUITING NCT06664788A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open SurgeryRECRUITING NCT07386366Wound Healing and Bacterial Adherence With Triclosan-Coated Sutures After Mandibular Impacted Third Molar SurgeryRECRUITING

Other records listing ETHICON, Inc. as applicant

PMA N12159Agent, absorbable hemostatic, non-collagen based PMA P880047Barrier, absorbable, adhesion PMA P240035Agent, absorbable hemostatic, collagen with polymeric additives K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

View all 34 devices →

Related Devices (Code: GAM)

K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic K253852MONOCRYL™ 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 K233265Monotime and Optime RPeters Surgical

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.