The following data is part of a premarket notification filed by Auris Surgical Robotics, Inc. with the FDA for Auris Robotic Endoscopy System (ares).
| Device ID | K152319 |
| 510k Number | K152319 |
| Device Name: | Auris Robotic Endoscopy System (ARES) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | AURIS SURGICAL ROBOTICS, INC. 125 SHOREWAY ROAD, SUITE D San Carlos, CA 94070 |
| Contact | Michael A. Daniel |
| Correspondent | Michael A. Daniel DANIEL & DANIEL CONSULTING, LLC 340 JONES LANE Gardnerville, NV 89460 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2016-05-26 |
| Summary: | summary |