K233240 is an FDA 510(k) clearance for the GERDX-System. This device is classified as a Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (Class II - Special Controls, product code ODE).
Submitted by G-Surg GmbH (Seeon-Seebruck, DE). The FDA issued a Cleared decision on June 21, 2024, 267 days after receiving the submission on September 28, 2023.
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 | K233240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | June 21, 2024 |
| Days to Decision | 267 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. |