www.fdanews.com/articles/176647-endogastric-solutions-esophyx-device-nabs-fda-clearance
EndoGastric Solutions’ EsophyX Device Nabs FDA Clearance
May 13, 2016
The FDA has granted 510(k) clearance to EndoGastric Solutions’ EsophyX Z device, which now will require fewer steps for restructuring the gastroesophageal valve to prevent gastroesophageal reflux disease.
The device is designed to restore the gastroesophageal barrier’s function during transoral incision-less fundoplication procedures.
The original model was cleared in 2007 and the third model was launched in 2015. — Anisa Jibrell