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RENASYS - RENASYS

by Smith & Nephew, Inc. 510(k)

Active United States Open recall

510(k) K142979

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142979 Date29 Apr 2015ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2848-2016 FDA Class II initiated 21 Jul 2016

    Sterility seal integrity failures on the Renasys Sterile Transparent Film

Specification

510(k)

510(k) Number
FDA Product Code
OMP
Models / Variants
RENASYS
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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