DeviceClearance

Product code OKO— General, Plastic Surgery

NPseal

Classification name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Device class
Class 2
Regulation
21 CFR 878.4683
Advisory panel
General, Plastic Surgery
Total cleared
17
First cleared
Most recent

FDA classification definition

“A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended 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.”

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

Market context for product code OKO

FDA has cleared 17 devices under product code OKO between 2009 and 2025, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code OKO

Recent clearances under product code OKO

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