Endogastric Solutions, Inc.
Endogastric Solutions, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2024, with 2 FDA device recalls on record.
Top product codes for Endogastric Solutions, Inc.
FDA recalls by Endogastric Solutions, Inc.
- Z-1982-2013 — EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
- Z-1136-2013 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Endogastric Solutions, Inc.
- K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
- K172811 — EsophyX Z, EsophyX2 HD
- K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
- K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories
- K143645 — EsophyX® Z Fastener Delivery Device
- K142113 — ESOPHYX2 HD
- K092400 — ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
- K091832 — ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
- K073644 — ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
- K071651 — EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
- K062875 — ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.