510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NWAClass II

Prosthesis, Tracheal, Preformed/Molded

21 CFR 878.3720 / General, Plastic Surgery
FDA source (opens on fda.gov)

NWA is the FDA product code for Prosthesis, Tracheal, Preformed/Molded, a class II device type, regulated under 21 CFR 878.3720. FDA's definition for this code reads: "The device is intended to provide support to weakened or constricting airway walls". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NWA
Device name
Prosthesis, Tracheal, Preformed/Molded
FDA definition
The device is intended to provide support to weakened or constricting airway walls.
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code NWA

By decision year
7 clearances under product code NWA with a decision year between 1987 and 2026, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NWA by decision year
YearClearances
19871
19891
19971
20191
20221
20241
20261

Applicants with the most clearances

Product code NWA
Applicants holding the most 510(k) clearances under product code NWA
ApplicantClearances
Novatech S.A.2
Bryan Corp.1
Hood Laboratories1
New Cos Inc. dba Visionair Solutions1
New Cos, Inc.1
VisionAir Solutions1

Companies listing this code with FDA

Companies whose registered establishments list this code