The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Esophyx Z, Esophyx2 Hd.
| Device ID | K172811 |
| 510k Number | K172811 |
| Device Name: | EsophyX Z, EsophyX2 HD |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | EndoGastric Solutions, Inc. 18109 NE 76th Street Suite 100 Redmond, WA 98052 |
| Contact | Steve Hoffman |
| Correspondent | Steve 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2017-10-19 |
| Summary: | summary |