Endogastric Solutions, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories, EsophyX Z, EsophyX2 HD, EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Endogastric Solutions, Inc. Gastroenterology & Urology ✕
11 devices
Cleared
Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Gastroenterology & Urology
28d
Cleared
Oct 19, 2017
EsophyX Z, EsophyX2 HD
Gastroenterology & Urology
31d
Cleared
CT
Jun 22, 2017
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z...
Gastroenterology & Urology
50d
Cleared
May 01, 2016
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
Gastroenterology & Urology
26d
Cleared
Mar 04, 2015
EsophyX® Z Fastener Delivery Device
Gastroenterology & Urology
72d
Cleared
Sep 30, 2014
ESOPHYX2 HD
Gastroenterology & Urology
57d
Cleared
Nov 06, 2009
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND...
Gastroenterology & Urology
92d
Cleared
Jul 22, 2009
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
Gastroenterology & Urology
30d
Cleared
Jun 27, 2008
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
Gastroenterology & Urology
184d
Cleared
Sep 14, 2007
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND...
Gastroenterology & Urology
88d
Cleared
Mar 09, 2007
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
Gastroenterology & Urology
164d