Clearance Summary
EsophyX® Z Device with SerosaFuse Fasteners and Accessories received FDA 510(k) clearance under submission number K160960, sponsored by Endogastric Solutions, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-05-01.
- Submission: K160960
- Applicant / Sponsor: Endogastric Solutions, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-05-01
Classification & Regulation
This clearance is catalogued under FDA product code ODE and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.