QFC — Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Class II
FDA product code QFC covers "Negative Pressure Wound Therapy Device For Reduction Of Wound Complications", a Class II medical device regulated under 21 CFR 878.4783. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFC
- Device Class
- Class II
- Regulation Number
- 878.4783
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223263 | 3m | Prevena Plus 125 Therapy Unit | February 13, 2023 |
| K203716 | smith and nephew medical limited | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negati | December 14, 2021 |
| DEN180013 | kci usa | PREVENA 125 and PREVENA PLUS 125 Therapy Units | April 19, 2019 |