Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3720](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3720) → NWA — Prosthesis, Tracheal, Preformed/Molded

# NWA · Prosthesis, Tracheal, Preformed/Molded

_General, Plastic Surgery · 21 CFR 878.3720 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA

## Overview

- **Product Code:** NWA
- **Device Name:** Prosthesis, Tracheal, Preformed/Molded
- **Regulation:** [21 CFR 878.3720](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3720)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

## Classification Rationale

Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

## Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243126](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K243126.md) | TRACHEOBRONXANE™ DUMON® | Novatech SA | Oct 29, 2024 | SESE |
| [K213969](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K213969.md) | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | Oct 7, 2022 | SESE |
| [K182743](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K182743.md) | Patient-Specific Airway Stent | New Cos, Inc. | Oct 23, 2019 | SESE |
| [K971509](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K971509.md) | ENDOXANE | Novatech SA | Aug 21, 1997 | ST |
| [K894380](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K894380.md) | DUMON TRACHEOBRONCHIAL STENT | Bryan Corp. | Oct 24, 1989 | SESE |
| [K873742](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K873742.md) | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Hood Laboratories | Oct 1, 1987 | SESE |

## Top Applicants

- Novatech SA — 2 clearances
- New Cos, Inc. — 1 clearance
- New Cos Inc. Dba Visionair Solutions — 1 clearance
- Hood Laboratories — 1 clearance
- Bryan Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA)

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