QFC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4783
- Medical specialty
- General, Plastic Surgery
- FDA definition
- A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Prevena Plus 125 Therapy Unit (K223263) | 3M | 2023-02-13 |
| 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 (K203716) | Smith and Nephew Medical Limited | 2021-12-14 |
| PREVENA 125 and PREVENA PLUS 125 Therapy Units (DEN180013) | Kci USA, Inc. | 2019-04-19 |
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Every clearance here is in the API, with alerts when new ones post.