The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Pico Single Use Negative Pressure Wound Therapy System.
| Device ID | K172519 |
| 510k Number | K172519 |
| Device Name: | PICO Single Use Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Samantha Neilson |
| Correspondent | Samantha Neilson Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223491086 | K172519 | 000 |
| 05000223491079 | K172519 | 000 |
| 05000223491062 | K172519 | 000 |
| 05000223491055 | K172519 | 000 |
| 05000223491048 | K172519 | 000 |
| 05000223491031 | K172519 | 000 |
| 05000223491024 | K172519 | 000 |
| 05000223491017 | K172519 | 000 |