Skip to content

Renasys Go 66021815

by Smith & Nephew Medical, Ltd.

Renasys Go 66021815 is a Class II device made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K152163 on 29 Sep 2016 and listed in FDA GUDID since 1 Dec 2016 (UDI-DI 00040565127392), 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) K152163

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 Number00040565127392 UDI-DI Date1 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152163 Date29 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152163 decided 29 Sep 2016 Active
  • FDA GUDID UDI-DI 00040565127392 listed 1 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152163
  2. Listed FDA GUDID 00040565127392

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Renasys Go
Generic name
Negative-pressure wound therapy system, battery-powered, reusable
Model / Ref / Catalog
66021815
Primary DI / UDI-DI
00040565127392
510(k) Number
FDA product code
OMP
GMDN term
Negative-pressure wound therapy system, battery-powered, reusable
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Negative-pressure wound therapy system, battery-powered, reusable

Cleared under the same submission (K152163)

and 8 more cleared under K152163

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

  • Prescription use
Other properties (14, all answered No)