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Vicryl Rapide Suture

by Ethicon Inc.

510(k) K944110

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)SN Traditional NumberK944110 Date18 Jan 1995DecidedStatusActive

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  • Withdrawn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
SN

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

VICRYL RAPIDE Suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. It is indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required. This suture is designed to provide temporary wound closure and support during the initial healing phase.

The suture is supplied as a sterile, single-use device and should be stored according to manufacturer instructions. It is available in various sizes and configurations for different surgical applications. The device has received FDA 510(k) clearance with the product code GAM and is classified as a Class II device for general and plastic surgery indications.

Other devices from Ethicon Inc.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is VICRYL RAPIDE Suture used for?

    VICRYL RAPIDE Suture is designed for superficial soft tissue approximation of the skin and mucosa, providing temporary wound support for 7-10 days during the initial healing phase.

  • Is VICRYL RAPIDE Suture single-use or reusable?

    VICRYL RAPIDE Suture is supplied as a sterile, single-use device and should not be reused. It must be discarded after a single surgical procedure to maintain sterility and prevent infection risks.

  • What sizes and configurations are available for VICRYL RAPIDE Suture?

    VICRYL RAPIDE Suture is available in various sizes and configurations to accommodate different surgical applications. The specific sizes and configurations should be selected based on the clinical requirements of the procedure.

  • How should VICRYL RAPIDE Suture be stored?

    VICRYL RAPIDE Suture should be stored according to the manufacturer's instructions to maintain its integrity and sterility. Proper storage conditions help ensure the product performs as intended during surgical procedures.