DeviceClearance

Product code QPX— General, Plastic Surgery

npSIMS Negative Pressure Surgical Incision Management System (npSIMS)

Classification name
Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
Device class
Class 2
Regulation
21 CFR 878.4683
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QPX under 21 CFR 878.4683, via openFDA

Market context for product code QPX

FDA has cleared 1 device under product code QPX, all in 2021, filed by 1 applicant company. 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.

Top applicants under product code QPX

Recent clearances under product code QPX

Data sourced from openFDA. This site is unofficial and independent of the FDA.