K171307 is an FDA 510(k) clearance for the EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories. This device is classified as a Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (Class II - Special Controls, product code ODE).
Submitted by Endogastric Solutions, Inc. (Redmond, US). The FDA issued a Cleared decision on June 22, 2017, 50 days after receiving the submission on May 3, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant..
| 510(k) Number | K171307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2017 |
| Decision Date | June 22, 2017 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODE - Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant. |