NWA

Prosthesis, Tracheal, Preformed/Molded

Product code
NWA
Device name
Prosthesis, Tracheal, Preformed/Molded
Device class
Class 2
21 CFR
21 CFR 878.3720
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-06-01.

NumberDecision dateApplicantDevice nameSummary
K2615412026-06-01VisionAir SolutionsVisionAir Enhanced Stock StentFDA
K2431262024-10-29Novatech SATRACHEOBRONXANE™ DUMON®PDF

1 summaries are archived here for direct download.

Official FDA classification page: NWA
Classification and pathway per current FDA publications. Data from openFDA (CC0).