QFC
2023-02-13
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
FDA product code QFC · 2 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4783
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2021-12-14 – 2023-02-13
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.
QFC
2021-12-14
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
View details →No matching devices.
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