Skip to content

Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed

by Ethicon Inc.

510(k) K962480

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962480 Date2 Aug 1996ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1608-2010 FDA Unclassified (pre-2012) initiated 20 Apr 2010

    Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.

    • Terminated Z-0021-2009 FDA Unclassified (pre-2012) initiated 11 Aug 2008

    Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAM
FDA applicant
ETHICON, Inc.
Device Class
Class II
Regulation
21 CFR Part 878.4493
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →