K163495 is an FDA 510(k) clearance for the AdvanCE capsule endoscope delivery device, a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II — Special Controls, product code NEZ), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 10, 2017, 87 days after receiving the submission on December 13, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K163495 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 13, 2016 |
| Decision Date | March 10, 2017 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1300 |