GERDX-System
FDA 510(k) K233240 · G-Surg GmbH
510(k) numberK233240
Submission
- Device name
- GERDX-System
- Applicant
- G-Surg GmbH
Seeon-Seebruck, DE - Received
- September 28, 2023
- Decision date
- June 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODE – Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Other 510(k)s with product code ODE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE · Special | Endogastric Solutions, Inc. | 04/26/2024SE |
| K172811 | EsophyX Z, EsophyX2 HDODE · Traditional | Endogastric Solutions, Inc. | 10/19/2017SE |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…ODE · Traditional | Endogastric Solutions, Inc. | 06/22/2017SE |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesODE · Special | Endogastric Solutions, Inc. | 05/01/2016SE |
| K151001 | MUSE SystemODE · Special | Medigus , Ltd. | 06/05/2015SE |
| K143645 | EsophyX® Z Fastener Delivery DeviceODE · Traditional | Endogastric Solutions, Inc. | 03/04/2015SE |
| K143634 | MUSE SystemODE · Special | Medigus , Ltd. | 01/20/2015SE |
| K142113 | ESOPHYX2 HDODE · Special | Endogastric Solutions, Inc. | 09/30/2014SE |
| K132151 | SRS Endoscopic Stapling SystemODE · Traditional | Medigus , Ltd. | 03/19/2014SE |
| K120299 | SRS Endoscopic Stapling SystemODE · Traditional | Medigus , Ltd. | 05/18/2012SE |
Questions and answers
When was GERDX-System cleared by the FDA?
GERDX-System (K233240) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 267 days after the submission was received.
What is the product code of K233240?
The FDA product code is ODE – Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd), a Class II (moderate risk) device regulated under 21 CFR 876.1500.