Panels › Gastroenterology, Urology › Product code ODE · Class 2
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulation 876.1500
0510(k)s in 12 months (20 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in ODE
| Company | 510(k)s | Recalls |
|---|---|---|
| Endogastric Solutions, Inc. | 8 | 2 |
| Ndo Surgical, Inc. | 5 | 0 |
| Medigus , Ltd. | 4 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Merit Medical Systems, Inc. | 0 | 2 |
| G-Surg GmbH | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Merit Medical Systems, Inc. Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly Open, Classified |
ODE | K240879 |
| Apr 21, 2025 | Merit Medical Systems, Inc. Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly Open, Classified |
ODE | K240879 |
| 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 | K092400 |
| 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 | K092400 |
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