The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Advance Capsule Endoscope Delivery Device.
| Device ID | K163495 |
| 510k Number | K163495 |
| Device Name: | AdvanCE Capsule Endoscope Delivery Device |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-13 |
| Decision Date | 2017-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995183605 | K163495 | 000 |