QPX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4683

Medical specialty

General, Plastic Surgery

FDA definition

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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