The following data is part of a premarket notification filed by Smith & Nephew Medical Ltd. with the FDA for Renasys Touch Negative Pressure Wound Therapy, Renasys Touch Canisters, Renasys Touch Carry Bag, Carry Strap, Renasys Y-connector, Renasys Touch Iv Pole/bed Clamp, Renasys Touch Class 2 Power Supply.
| Device ID | K153209 |
| 510k Number | K153209 |
| Device Name: | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SMITH & NEPHEW MEDICAL LTD. 101 HESSLE RD. Hull, GB Hu3 2bn |
| 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 | 2015-11-05 |
| Decision Date | 2016-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223491567 | K153209 | 000 |
| 30040565126563 | K153209 | 000 |
| 30040565126600 | K153209 | 000 |
| 30040565126617 | K153209 | 000 |
| 05000223497583 | K153209 | 000 |
| 30040565126525 | K153209 | 000 |
| 30040565126532 | K153209 | 000 |
| 30040565126549 | K153209 | 000 |
| 00040565126630 | K153209 | 000 |
| 05000223495527 | K153209 | 000 |
| 00040565126586 | K153209 | 000 |
| 00040565126883 | K153209 | 000 |
| 00040565126494 | K153209 | 000 |
| 30040565126556 | K153209 | 000 |