Prosthesis, Tracheal, Preformed/Molded
The Preformed/Molded Tracheal Prosthesis is a surgically implanted airway device intended to provide structural support to weakened or constricting airway walls, maintaining tracheal patency in patients with tracheal abnormalities. It is an FDA Class 2 implant regulated under 21 CFR 878.3720 in the General and Plastic Surgery specialty, reviewed by the Anesthesiology panel, with product code NWA, requiring 510(k) clearance. The implant flag is set reflecting its surgical placement within the trachea. It does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NWA
- Device Class
- FDA class 2
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to provide support to weakened or constricting airway walls.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261541 | VisionAir Enhanced Stock Stent | Jun 01, 2026 | Substantially Equivalent | VisionAir Solutions |
| K243126 | TRACHEOBRONXANE DUMON® | Oct 29, 2024 | Substantially Equivalent | Novatech SA |
| K213969 | VisionAir Patient-Specific Airway Stent | Oct 07, 2022 | Substantially Equivalent | New Cos Inc. Dba Visionair Solutions |
| K182743 | Patient-Specific Airway Stent | Oct 23, 2019 | Substantially Equivalent | New Cos, Inc. |
| K971509 | ENDOXANE | Aug 21, 1997 | Substantially Equivalent - Subject to Tracking Reg. | Novatech SA |
| K894380 | DUMON TRACHEOBRONCHIAL STENT | Oct 24, 1989 | Substantially Equivalent | Bryan Corp. |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Oct 01, 1987 | Substantially Equivalent | Hood Laboratories |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.