Endogastric Solutions, Inc.
Redmond, WA, US
Endogastric Solutions, Inc. appears in FDA device records in Redmond, WA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Endogastric Solutions, Inc. between 2007 and 2024. The busiest year on record is 2007, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | ODE | Substantially Equivalent | |
| K172811 | EsophyX Z, EsophyX2 HD | ODE | Substantially Equivalent | |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | ODE | Substantially Equivalent | |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | ODE | Substantially Equivalent | |
| K143645 | EsophyX® Z Fastener Delivery Device | ODE | Substantially Equivalent | |
| K142113 | ESOPHYX2 HD | ODE | Substantially Equivalent | |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | ODE | Substantially Equivalent | |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | OCW | Substantially Equivalent | |
| K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | OCW | Substantially Equivalent | |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | ODE | Substantially Equivalent | |
| K062875 | ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES | OCW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1982-2013 | EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. | Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device. | Class II | Terminated | |
| Z-1136-2013 | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis | EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain