K142113 is an FDA 510(k) clearance for the 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. (Gardnerville, US). The FDA issued a Cleared decision on September 30, 2014, 57 days after receiving the submission on August 4, 2014.
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 | K142113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2014 |
| Decision Date | September 30, 2014 |
| Days to Decision | 57 days |
| Submission Type | Special |
| 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. |