Clearance Summary
Auris Robotic Endoscopy System (ARES) received FDA 510(k) clearance under submission number K152319, sponsored by Auris Surgical Robotics, Inc.. 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 2016-05-26.
- Submission: K152319
- Applicant / Sponsor: Auris Surgical Robotics, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2016-05-26
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.