The following data is part of a premarket notification filed by Smith Nephew Medical Limited with the FDA for Pico 7 Single Use Negative Pressure Wound Therapy System, Pico 14 Single Use Negative Pressure Wound Therapy System, Pico Fluid Management Packs.
| Device ID | K211318 |
| 510k Number | K211318 |
| Device Name: | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Steeve Lamvohee |
| Correspondent | Steeve Lamvohee 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 | 2021-04-30 |
| Decision Date | 2022-01-05 |