EsophyX® Z Fastener Delivery Device— 510(k) K143645

Substantially Equivalent

Endogastric Solutions, Inc.

FDA 510(k) clearance K143645 for EsophyX® Z Fastener Delivery Device, Substantially Equivalent on 2015-03-04. Applicant: Endogastric Solutions, Inc..

Clearance details

Applicant: Endogastric Solutions, Inc.
Product code: Code ODE
Advisory panel: Gastroenterology, Urology
Date received: 2014-12-22
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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