The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys Go.
| Device ID | K152163 |
| 510k Number | K152163 |
| Device Name: | RENASYS GO |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716 |
| Contact | Laura Reynolds |
| Correspondent | Laura Reynolds SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2016-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223491000 | K152163 | 000 |
| 05000223491475 | K152163 | 000 |
| 30040565127324 | K152163 | 000 |
| 30040565127331 | K152163 | 000 |
| 30040565126952 | K152163 | 000 |
| 30040565125306 | K152163 | 000 |
| 00040565125572 | K152163 | 000 |
| 00040565127149 | K152163 | 000 |
| 00040565127392 | K152163 | 000 |
| 00040565126944 | K152163 | 000 |
| 05000223465131 | K152163 | 000 |
| 05000223465148 | K152163 | 000 |
| 30040565125290 | K152163 | 000 |