Skip to content

Renasys Touch 66801276

by Smith & Nephew Medical, Ltd.

Renasys Touch 66801276 is a Class II device made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K153209 on 4 Aug 2016 and listed in FDA GUDID since 2 Nov 2016 (UDI-DI 00040565126555), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K153209

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 Number00040565126555 UDI-DI Date2 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153209 Date4 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153209 decided 4 Aug 2016 Active
  • FDA GUDID UDI-DI 00040565126555 listed 2 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153209
  2. Listed FDA GUDID 00040565126555

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Renasys Touch
Generic name
Medical bag
Model / Ref / Catalog
66801276
Primary DI / UDI-DI
00040565126555
510(k) Number
FDA product code
OMP
GMDN term
Medical bag
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical bag

Cleared under the same submission (K153209)

and 8 more cleared under K153209

Similar devices in this category

Other devices filed under Medical bag.

Other devices from Smith & Nephew Medical, Ltd.

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

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)