Endogastric Solutions Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 11
- Inspections
- 7
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1982-2013 | Class II | EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. | June 6, 2013 |
| Z-1136-2013 | Class II | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-0 | February 4, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | April 26, 2024 |
| K172811 | EsophyX Z, EsophyX2 HD | October 19, 2017 |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Faste | June 22, 2017 |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | May 1, 2016 |
| K143645 | EsophyX® Z Fastener Delivery Device | March 4, 2015 |
| K142113 | ESOPHYX2 HD | September 30, 2014 |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | November 6, 2009 |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | July 22, 2009 |
| K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | June 27, 2008 |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | September 14, 2007 |
| K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | March 9, 2007 |