Renasys Go 66021496
by Smith & Nephew Medical, Ltd.
Renasys Go 66021496 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 05000223491000), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05000223491000 | Date1 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152163 | Date29 Sep 2016 | StatusActive |
Official records
- AccessGUDID record 05000223491000
- FDA 510(k) database K152163
Across registries
- FDA 510(k) K152163 decided 29 Sep 2016 Active
- FDA GUDID UDI-DI 05000223491000 listed 1 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K152163
- Listed FDA GUDID 05000223491000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Renasys Go
- Generic name
- Negative-pressure wound therapy system, battery-powered, reusable
- Model / Ref / Catalog
- 66021496
- Primary DI / UDI-DI
- 05000223491000
- 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
- MRI safety
- MR Unsafe
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