EsophyX® Z Fastener Delivery Device— 510(k) K143645
Substantially EquivalentEndogastric Solutions, Inc.
FDA 510(k) clearance K143645 for EsophyX® Z Fastener Delivery Device, Substantially Equivalent on 2015-03-04. 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
- Traditional
- Location
- Redmond, WA, US
Recent devices under product code ODE
view all- K233240 — GERDX-System
- 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
More clearances from Endogastric Solutions, Inc.
view all- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.