K172811 is an FDA 510(k) clearance for the EsophyX Z, EsophyX2 HD. 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 October 19, 2017, 31 days after receiving the submission on September 18, 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 | K172811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2017 |
| Decision Date | October 19, 2017 |
| Days to Decision | 31 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. |