510(k) K261541
K261541 is an FDA 510(k) premarket notification submitted by VisionAir Solutions for the device "VisionAir Enhanced Stock Stent". The FDA issued a decision of Substantially Equivalent on June 1, 2026. The device falls under product code NWA (Prosthesis, Tracheal, Preformed/Molded), a Class II device regulated under 21 CFR 878.3720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2026
- Date Received
- May 8, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Preformed/Molded
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type
The device is intended to provide support to weakened or constricting airway walls.