K261541
- 510(k) number
- K261541
- Device name
- VisionAir Enhanced Stock Stent
- Applicant
- VisionAir Solutions OH · US
- Product code
- NWA — Prosthesis, Tracheal, Preformed/Molded
- Decision date
- 2026-06-01
- Date received
- 2026-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K261541.pdf
Official FDA record: K261541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.