FDA.reportPublic FDA data

510(k) K240879

Device
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Applicant
Endogastric Solutions, Inc.
510(k) number
K240879
Product code
ODE
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-26
Date received
2024-03-29
Regulation
876.1500
Classification name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shala Famil
Address
18109 NE 76th St. Redmond WA US 98052 98052

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233240GERDX-SystemG-Surg GmbH2024-06-21
K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.2017-10-19
K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.2017-06-22
K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.2016-05-01
K151001MUSE SystemMedigus , Ltd.2015-06-05
K143645EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc.2015-03-04
K143634MUSE SystemMedigus , Ltd.2015-01-20
K142113ESOPHYX2 HDEndogastric Solutions, Inc.2014-09-30
K132151SRS ENDOSCOPIC STAPLING SYSTEMMedigus , Ltd.2014-03-19
K120299SRS ENDOSCOPIC STAPLING SYSTEMMedigus , Ltd.2012-05-18
K092400ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5Endogastric Solutions, Inc.2009-11-06
K072125ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENTNdo Surgical, Inc.2007-10-18
K071553ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATORNdo Surgical, Inc.2007-09-18
K071651EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIESEndogastric Solutions, Inc.2007-09-14
K032820MODIFICATION TO ENDOSCOPIC PLICATION SYSTEMNdo Surgical, Inc.2003-10-23