The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Renasys Y-connector; Renasys Touch.
| Device ID | K181204 |
| 510k Number | K181204 |
| Device Name: | RENASYS Y-Connector; RENASYS TOUCH |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Sam Greenhalgh |
| Correspondent | Sam Greenhalgh Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223493592 | K181204 | 000 |
| 05000223496296 | K181204 | 000 |
| 05000223494476 | K181204 | 000 |