The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Esophyx2 Hd Device With Serosafuse Fasteners And Accessories, Esophyx Z Device With Serosafuse Fasteners And Accessories.
| Device ID | K171307 |
| 510k Number | K171307 |
| Device Name: | EsophyX2 HD Device With SerosaFuse Fasteners And Accessories, 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 | 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 | 2017-05-03 |
| Decision Date | 2017-06-22 |
| Summary: | summary |