QPX
- Product code
- QPX
- Device name
- Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4683
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification 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.
Official FDA classification page: QPX
Classification and pathway per current FDA publications. Data from openFDA (CC0).