DeviceClearance

Product code NWA— General, Plastic Surgery

DUMON TRACHEOBRONCHIAL STENT

Classification name
Prosthesis, Tracheal, Preformed/Molded
Device class
Class 2
Regulation
21 CFR 878.3720
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

FDA classification definition

“The device is intended to provide support to weakened or constricting airway walls.”

— U.S. Food and Drug Administration, device classification record for product code NWA under 21 CFR 878.3720, via openFDA

Market context for product code NWA

FDA has cleared 7 devices under product code NWA between 1987 and 2026, filed by 6 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 NWA

Recent clearances under product code NWA

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