FDA-Device2013-04-24Class II
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
Endogastric Solutions Inc
Hazard
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Sold states
Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
Affected count
190
Manufactured in
8210 154th Ave NE, N/A, Redmond, WA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1136-2013Don't want to check this manually?
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