FDA Product Code
FDA Product Code QFC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4783
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023-02-13 | Traditional | PDF ↗ |
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | Smith and Nephew Medical Limited | 2021-12-14 | Traditional | PDF ↗ |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Kci USA, Inc. | 2019-04-19 | Direct | — |
Product code QFC · Class II · General, Plastic Surgery. Data: openFDA.