Endogastric Solutions, Inc.
Medical device manufacturer in Redmond, WA.
11510(k) clearances
0PMA approvals
2recalls
510(k) clearances
| 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 |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesODE · Special | 05/01/2016SE |
| 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 |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1982-2013 Class II | EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001…Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold… | 06/06/2013Terminated |
| Z-1136-2013 Class II | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part…EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the… | 02/04/2013Terminated |