Endochoice, Inc.
Country not established
- Devices
- 111
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Endochoice, Inc. makes
Endochoice, Inc. manufactures endoscopic devices for biliary, tracheal/bronchial, and esophageal procedures, including self-expanding metal stents (BONASTENT series), endoscopic ligators (AUTOBAND), irrigation systems (water bottle caps), and single-use valves (SmartStart, Seal). The portfolio also includes endoscopic forceps, a gastroscopy system (Fuse), and a processor-based endoscopic suite (Fuse Endoscopic System with FuseBox).
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 111 devicesShowing 1-50 of 111
Company details
- DUNS number
- 014154279
- [email protected]
- Phone
- 888-632-3636
FDA recalls
FDA recall records list 1 recall initiated by Endochoice, Inc., initiated on 2015-12-18. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 18 Dec 2015 Z-0694-2016 Class II Terminated The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
Full distribution text
- 18 Dec 2015 Z-0694-2016 Class II Terminated The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
Frequently asked questions
How many devices does Endochoice, Inc. have in the registry?
The registry currently lists 111 devices for Endochoice, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endochoice, Inc.'s devices?
Among its 50 most recently registered devices, Endochoice, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Endochoice, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Endochoice, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Endochoice, Inc.?
FDA recall records list 1 recall initiated by Endochoice, Inc., the most recent initiated on 18 Dec 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Endochoice, Inc. in the registry?
The most recently registered devices listed for Endochoice, Inc. include Rescue® DGC-383, Fuse FSC-3300-SL-R, Fuse SCT-468-02 and Fuse® FDEMO-F7525.