EsophyX® Z Device With SerosaFuse Fasteners And Accessories
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
ENDOGASTRIC SOLUTIONS, INC.
The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Esophyx® Z Device With Serosafuse Fasteners And Accessories.
Pre-market Notification Details
| Device ID | K160960 |
| 510k Number | K160960 |
| Device Name: | EsophyX® Z Device With SerosaFuse Fasteners And Accessories |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | ENDOGASTRIC SOLUTIONS, INC. 18109 NE 76TH STREET SUITE 100 Redmond, WA 98052 |
| Contact | Steven J Hoffman |
| Correspondent | Steven J Hoffman ENDOGASTRIC SOLUTIONS, INC. 18109 NE 76TH STREET SUITE 100 Redmond, WA 98052 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-05-01 |
| Summary: | summary |
Trademark Results [EsophyX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESOPHYX 78935283 3370845 Live/Registered |
EndoGastric Solutions, Inc. 2006-07-21 |
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