Recall Z-1136-2013— Endogastric Solutions Inc
Class II · Terminated
Class II FDA medical device recall by Endogastric Solutions Inc, initiated 2013-02-04, terminated 2013-07-02. It names one FDA 510(k) clearance: K092400. Product: 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. Reason: EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians..
- Recalling firm
- Endogastric Solutions Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-04
- Terminated
- 2013-07-02
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Data sourced from openFDA. This site is unofficial and independent of the FDA.