FDA.reportPublic FDA data

ENDOGASTRIC SOLUTIONS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30054733913005473391ENDOGASTRIC SOLUTIONS, INC.1N2020-04-2518109 NE 76th St Suite 100 REDMOND WA US 98052

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810275011065EsophyX2 HD - EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories425-307-9269customerservice@endogastricsolutions.com
00810275011072EsophyX Z - EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories425-307-9269customerservice@endogastricsolutions.com
00810275011089EsophyX Z+ - EsophyX Z+ Fastener Delivery Device with SerosaFuse Fasteners and Accessories425-307-9269customerservice@endogastricsolutions.com
008102750130146.5mm Cartridge - "Cartridge, 20 Fasteners, 0.010"" Slot, 6.5mm Web"425-307-9269customerservice@endogastricsolutions.com
008102750130217.5mm Cartridge - "Cartridge, 20 Fasteners, 0.010"" Slot, 7.5mm Web"425-307-9269customerservice@endogastricsolutions.com
008102750130386.5mm & 7.5mm Cartridge - Cartridge, 40 Implantable Fasteners, 6.5mm & 7.5mm Web Length425-307-9269customerservice@endogastricsolutions.com
00810275013052SerosaFuse® 7.5mm Implantable Fastener Cartridges - 2 Cartridges, 40 Implantable Fasteners, 7.5mm Web Length425-307-9269customerservice@endogastricsolutions.com
00810275014011SerosaFuse® Implantable Fastener Kit - Single kit consists of 1 each R2007 EsophyX Z+ Fastener Delivery Device and 1 each R2375 SerosaFuse Implantable Fastener Cartridge425-307-9269customerservice@endogastricsolutions.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
669771573437925K172811EsophyX Z, EsophyX2 HDODE2017-10-19
669771334366025K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesODE2017-06-22
669771336726797K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesODE2016-05-01
669771879268477K143645EsophyX® Z Fastener Delivery DeviceODE2015-03-04
669771735364602K142113ESOPHYX2 HDODE2014-09-30
669772068905464K092400ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5ODE2009-11-06
669771456992999K091832ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENEROCW2009-07-22
669771788656895K073644ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIESOCW2008-06-27
669771495779805K071651EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIESODE2007-09-14
669771332992065K062875ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIESOCW2007-03-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODE72017-10-19
OCW32009-07-22

PMN#

GUDID#