Clearance Summary
Monarch Bronchoscope received FDA 510(k) clearance under submission number K203614, sponsored by Auris Health, Inc., A Johnson and Johnson Family Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-03-11.
- Submission: K203614
- Applicant / Sponsor: Auris Health, Inc., A Johnson and Johnson Family Company
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2021-03-11
Classification & Regulation
This clearance is catalogued under FDA product code QNW and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.