Product code QFC— General, Plastic Surgery
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
- Classification name
- Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- Device class
- Class 2
- Regulation
- 21 CFR 878.4783
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 3
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QFC
FDA has cleared devices under product code QFC between 2019 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2021
- 2019
Top applicants under product code QFC
Recent clearances under product code QFC
- K223263 — Prevena Plus 125 Therapy Unit
- 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
- DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units
Data sourced from openFDA. This site is unofficial and independent of the FDA.