510(k) K261541
- Device
- VisionAir Enhanced Stock Stent
- Applicant
- VisionAir Solutions
- 510(k) number
- K261541
- Product code
- NWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-01
- Date received
- 2026-05-08
- Regulation
- 878.3720
- Classification name
- Prosthesis, Tracheal, Preformed/Molded
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jacob Marsh
- Address
- 1800 Triplett Blvd. Akron OH US 44306 44306
FDA Registration Numbers#
- 9613846
- 3010197296
- 1220850
Source Documents#
Other 510(k) Records For Product Code NWA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 2024-10-29 |
| K213969 | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | 2022-10-07 |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | 2019-10-23 |
| K971509 | ENDOXANE | Novatech SA | 1997-08-21 |
| K894380 | DUMON TRACHEOBRONCHIAL STENT | Bryan Corp. | 1989-10-24 |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Hood Laboratories | 1987-10-01 |