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Antimicrobial Gauze 66801691

by Smith & Nephew Medical, Ltd.

Antimicrobial Gauze 66801691 is a Class II device made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K142979 on 29 Apr 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00040565127125), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K142979

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00040565127125 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142979 Date29 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142979 decided 29 Apr 2015 Active
  • FDA GUDID UDI-DI 00040565127125 listed 20 Sep 2016 Listed

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K142979
  2. Recall initiated FDA recalls Z-2848-2016
  3. Listed FDA GUDID 00040565127125

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Antimicrobial Gauze
Generic name
Woven gauze roll/sheet
Model / Ref / Catalog
66801691
Primary DI / UDI-DI
00040565127125
510(k) Number
FDA product code
OMP
GMDN term
Woven gauze roll/sheet
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Woven gauze roll/sheet

Cleared under the same submission (K142979)

and 8 more cleared under K142979

Similar devices

Other devices filed under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Other devices from Smith & Nephew Medical, Ltd.

See all devices from Smith & Nephew Medical, Ltd. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)