FDA 510(k) K152319, Auris Robotic Endoscopy System (ARES), by Auris Surgical Robotics, Inc.
FDA 510(k) K152319, Auris Robotic Endoscopy System (ARES), by Auris Surgical Robotics, Inc.
| 510(k) Number | K152319 |
| Device Classification Name | Bronchoscope (Flexible Or Rigid) |
| Device Name | Auris Robotic Endoscopy System (ARES) |
| Applicant | Auris Surgical Robotics, Inc. 125 Shoreway Rd., Suite D San Carlos, CA 94070 |
| Regulation Number | 874.468 |
| Classification Product Code | EOQ |
| Date Received | 08/17/2015 |
| Decision Date | 05/26/2016 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Ear Nose & Throat |
| 510k Review Panel | Ear Nose & Throat |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 3011 |
| Redacted Pages | 2711 |
| Unredacted Pages | 300 |
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