EsophyX® Z Device with SerosaFuse Fasteners and Accessories
FDA 510(k) K160960 · Endogastric Solutions, Inc.
510(k) numberK160960
Submission
- Device name
- EsophyX® Z Device with SerosaFuse Fasteners and Accessories
- Applicant
- Endogastric Solutions, Inc.
Redmond, WA, US - Received
- April 5, 2016
- Decision date
- May 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K233240 | GERDX-SystemODE · Traditional | G-Surg GmbH | 06/21/2024SE |
| 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 |
| 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 |
More from Medigus , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE · Special | 04/26/2024SE |
| K172811 | EsophyX Z, EsophyX2 HDODE · Traditional | 10/19/2017SE |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…ODE · Traditional | 06/22/2017SE |
| K143645 | EsophyX® Z Fastener Delivery DeviceODE · Traditional | 03/04/2015SE |
| K142113 | ESOPHYX2 HDODE · Special | 09/30/2014SE |
| K092400 | Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model…ODE · Special | 11/06/2009SE |
| K091832 | Endogastric Solutions Stomaphyx System with Serosafuse FastenerOCW · Special | 07/22/2009SE |
| K073644 | Endogastric Solutions Stomaphyx Device and AccessoriesOCW · Traditional | 06/27/2008SE |
| K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesODE · Traditional | 09/14/2007SE |
| K062875 | Endogastric Stomaphyx Device and AccessoriesOCW · Traditional | 03/09/2007SE |
Questions and answers
When was EsophyX® Z Device with SerosaFuse Fasteners and Accessories cleared by the FDA?
EsophyX® Z Device with SerosaFuse Fasteners and Accessories (K160960) received a 510(k) decision of Substantially Equivalent on May 1, 2016, 26 days after the submission was received.
What is the product code of K160960?
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.