2 results
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18ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
FDA Enforcement
Class II
·Terminated·Endogastric Solutions Inc·August 28, 2013
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 for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
FDA Enforcement
Class II
·Terminated·Endogastric Solutions Inc·April 24, 2013