Endogastric Solutions, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Endogastric Solutions, Inc.” (first 2007, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Since 2017 the median was 31 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 57 |
| 2015 | 1 | 72 |
| 2016 | 1 | 26 |
| 2017 | 2 | 40 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Endogastric Solutions, Inc. took a median 31 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODE | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | 8 | 8 |
| OCW | Endoscopic Tissue Approximation Device | 3 | 3 |
Review panels
Most recent Endogastric Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | ODE | 2024-04-26 | 28 |
| K172811 | EsophyX Z, EsophyX2 HD | ODE | 2017-10-19 | 31 |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | ODE | 2017-06-22 | 50 |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | ODE | 2016-05-01 | 26 |
| K143645 | EsophyX® Z Fastener Delivery Device | ODE | 2015-03-04 | 72 |
| K142113 | ESOPHYX2 HD | ODE | 2014-09-30 | 57 |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | ODE | 2009-11-06 | 92 |
| K091832 | ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER | OCW | 2009-07-22 | 30 |
| K073644 | ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES | OCW | 2008-06-27 | 184 |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | ODE | 2007-09-14 | 88 |
1 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-06-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Endogastric Solutions, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01647958: The EndoGastric Solutions TEMPO Trial (Completed, started 2012-06-01)
- NCT01136980: Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study (Completed, started 2011-04)
- NCT01118585: Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD) (Completed, started 2010-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Endogastric Solutions, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Endogastric Solutions, Inc.” (first 2007, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endogastric Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endogastric Solutions, Inc. is 57 days. Since 2017: 31 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Endogastric Solutions, Inc.?
The most frequent FDA product codes under this applicant name are ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd), 8); OCW (Endoscopic Tissue Approximation Device, 3).
Next steps
- See all 11 Endogastric Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ODE, Endogastric Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.