510(k) K240879 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
| Applicant | Endogastric Solutions, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Apr 26, 2024 |
| Received | Mar 29, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240879
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Merit Medical Systems, Inc. Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly Open, Classified |
ODE | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.