EsophyX® Z Device with SerosaFuse Fasteners and Accessories— 510(k) K160960

Substantially Equivalent

Endogastric Solutions, Inc.

FDA 510(k) clearance K160960 for EsophyX® Z Device with SerosaFuse Fasteners and Accessories, Substantially Equivalent on 2016-05-01. Applicant: Endogastric Solutions, Inc..

Clearance details

Applicant: Endogastric Solutions, Inc.
Product code: Code ODE
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-05
Decision date: 2016-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.