The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Pico 14 Single Use Negative Pressure Wound Therapy System.
| Device ID | K191760 |
| 510k Number | K191760 |
| Device Name: | PICO 14 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 | 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 | 2019-07-01 |
| Decision Date | 2019-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223495473 | K191760 | 000 |
| 05000223495398 | K191760 | 000 |
| 05000223495404 | K191760 | 000 |
| 05000223495411 | K191760 | 000 |
| 05000223495428 | K191760 | 000 |
| 05000223495435 | K191760 | 000 |
| 05000223495442 | K191760 | 000 |
| 05000223495459 | K191760 | 000 |
| 05000223495466 | K191760 | 000 |
| 05000223495381 | K191760 | 000 |