510(k) K092400 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
| Applicant | Endogastric Solutions, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Aug 6, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2013 | Endogastric Solutions Inc EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002.
Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. Terminated |
ODE | None listed |
| Apr 17, 2013 | Endogastric Solutions Inc 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 fo Terminated |
ODE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.