Auris Surgical Robotics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Auris Surgical Robotics, Inc. makes
Auris Surgical Robotics, Inc. manufactures robotic systems for minimally invasive surgical procedures, including the Monarch Endoscopy Platform and the Auris Robotic Endoscopy System (ARES). These devices are designed to assist in endoscopic surgeries, providing enhanced precision and control for procedures within the body’s cavities and organs. The Monarch Platform integrates robotic arms and imaging technology to support flexible endoscopy, while ARES is tailored for robotic-assisted gastrointestinal endoscopy.
The company’s products fall under FDA Class II medical devices and are authorised through the 510(k) clearance pathway in the United States. The portfolio is regulated under the US Food and Drug Administration’s medical device regulations, with listings maintained in the FDA’s 510(k) database. Auris Surgical Robotics, Inc. is headquartered in the United States.
Catalogue
Monarch Endoscopy Platform (Monarch Platform) Ref K173760
Regimes: 510(k) Registry: 510(k)Auris Robotic Endoscopy System (ARES) Ref K152319
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Auris Surgical Robotics, Inc. have in the registry?
The registry currently lists 2 devices for Auris Surgical Robotics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Auris Surgical Robotics, Inc.'s devices?
Among its 2 most recently registered devices, Auris Surgical Robotics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Auris Surgical Robotics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Auris Surgical Robotics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Auris Surgical Robotics, Inc. in the registry?
The most recently registered devices listed for Auris Surgical Robotics, Inc. include Monarch Endoscopy Platform (Monarch Platform) and Auris Robotic Endoscopy System (ARES).