QFC

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Product code

QFC

Device name

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Device class

Class 2

21 CFR

21 CFR 878.4783

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).