Company · US
Endogastric Solutions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2024. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 2024 | K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. | ODE |
| Oct 19, 2017 | K172811 | EsophyX Z, EsophyX2 HD Endogastric Solutions, Inc. | ODE |
| Jun 22, 2017 | K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. | ODE |
| May 1, 2016 | K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc. | ODE |
| Mar 4, 2015 | K143645 | EsophyX® Z Fastener Delivery Device Endogastric Solutions, Inc. | ODE |
| Sep 30, 2014 | K142113 | ESOPHYX2 HD Endogastric Solutions, Inc. | ODE |
| Nov 6, 2009 | K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 Endogastric Solutions, Inc. | ODE |
| Jul 22, 2009 | K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER Endogastric Solutions, Inc. | OCW |
| Jun 27, 2008 | K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES Endogastric Solutions, Inc. | OCW |
| Sep 14, 2007 | K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES Endogastric Solutions, Inc. | ODE |
| Mar 9, 2007 | K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES Endogastric Solutions, Inc. | OCW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2013 | Endogastric Solutions Inc EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002.
Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. Terminated |
ODE | K092400 |
| Apr 17, 2013 | Endogastric Solutions Inc EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***"
Designed fo Terminated |
ODE | K092400 |