Clearance Summary
VisionAir Patient-Specific Airway Stent received FDA 510(k) clearance under submission number K213969, sponsored by New Cos Inc. Dba Visionair Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2022-10-07.
- Submission: K213969
- Applicant / Sponsor: New Cos Inc. Dba Visionair Solutions
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3720
- Decision date: 2022-10-07
Classification & Regulation
This clearance is catalogued under FDA product code NWA and 21 CFR 878.3720, within the General, Plastic Surgery review panel as a Class II device.