Renasys Go
510(k) K152163
Renasys Go is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K152163 on 29 Sep 2016, 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 | FDA 510(k)SESE | NumberK152163 | Date29 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K152163
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OMP
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152163
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| RENASYS GO 66020914 | 66020914 / 66020914 | 00040565127323 | On the market | |
| RENASYS GO 66020916 | 66020916 / 66020916 | 00040565127330 | On the market | |
| RENASYS GO 66021496 | 66021496 / 66021496 | 05000223491000 | On the market | |
| RENASYS GO 66021739 | 66021739 / 66021739 | 00040565127149 | On the market | |
| RENASYS GO 66021814 | 66021814 / 66021814 | 00040565125572 | On the market | |
| RENASYS GO 66021815 | 66021815 / 66021815 | 00040565127392 | On the market | |
| RENASYS GO 66800061 | 66800061 / 66800061 | 00040565125305 | On the market | |
| RENASYS GO 66800162 | 66800162 / 66800162 | 05000223465186 | On the market | |
| RENASYS GO 66800163 | 66800163 / 66800163 | 05000223465193 | On the market | |
| RENASYS GO 66800603 | 66800603 / 66800603 | 00040565125299 | On the market | |
| RENASYS GO 66801558 | 66801558 / 66801558 | 00040565126951 | On the market | |
| RENASYS GO SERVICE MANUAL 66021206 | 66021206 / 66021206 | 00040565127354 | On the market | |
| RENASYS GO v2 HOME 66801496 | 66801496 / 66801496 | 00040565126944 | On the market |
Similar devices
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- PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack by Smith & Nephew Medical, Ltd.