Clearance Summary
Otoplan received FDA 510(k) clearance under submission number K203486, sponsored by Cascination AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-08-20.
- Submission: K203486
- Applicant / Sponsor: Cascination AG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2021-08-20
Classification & Regulation
This clearance is catalogued under FDA product code QQE and 21 CFR 892.2050, within the Radiology review panel as a Class II device.