The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Endogastric Solutions Esophyx2 System With Serosafuse Fastener And Accessories, Model 2.7.5.
| Device ID | K092400 |
| 510k Number | K092400 |
| Device Name: | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond, WA 98052 |
| Contact | Steve Hoffman |
| Correspondent | Steve Hoffman ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE 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 | 2009-08-06 |
| Decision Date | 2009-11-06 |
| Summary: | summary |