EsophyX® Z Fastener Delivery Device
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 Fastener Delivery Device.
Pre-market Notification Details
| Device ID | K143645 |
| 510k Number | K143645 |
| Device Name: | EsophyX® Z Fastener Delivery Device |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | ENDOGASTRIC SOLUTIONS, INC. 18109 NE 76TH ST, SUITE 100 Redmond, WA 98052 |
| Contact | Darren Crow |
| Correspondent | Steven J Hoffman ENDOGASTRIC SOLUTIONS, INC. 18109 NE 76TH ST, SUITE 100 Redmond, WA 98052 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-03-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810275011072 | K143645 | 000 |
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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