EsophyX Z+ Device with SerosaFuse Fasteners and Accessories— 510(k) K240879
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K240879 for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories, Substantially Equivalent on 2024-04-26. Applicant: Endogastric Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Endogastric Solutions, Inc.
- Product code
- Code ODE
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redmond, WA, US
Recent devices under product code ODE
view allMore clearances from Endogastric Solutions, Inc.
view all- 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
Recalls naming K240879
K-number listed on FDA's recall record- Z-1640-2025 — Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Z-1641-2025 — Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K240879.
Data sourced from openFDA. This site is unofficial and independent of the FDA.