Product code QPX

Device name

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

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4683

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset