DEN160014 is an FDA 510(k) submission for the remOVE System. This device is classified as a Endoscopic Electrosurgical Clip Cutting System (Class II - Special Controls, product code QAG).
Submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Not Cleared (DENG) decision on December 22, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4310. To Fragment Metallic Clips And Remove Them From The Digestive Tract..
| 510(k) Number | DEN160014 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 11, 2016 |
| Decision Date | December 22, 2017 |
| Days to Decision | 620 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QAG - Endoscopic Electrosurgical Clip Cutting System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4310 |
| Definition | To Fragment Metallic Clips And Remove Them From The Digestive Tract. |