The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Esophyx2 Hd.
| Device ID | K142113 |
| 510k Number | K142113 |
| Device Name: | ESOPHYX2 HD |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | ENDOGASTRIC SOLUTIONS, INC. 340 JONES LANE Gardnerville, NV 89640 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel ENDOGASTRIC SOLUTIONS, INC. 340 JONES LANE Gardnerville, NV 89640 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810275013038 | K142113 | 000 |
| 00810275013021 | K142113 | 000 |
| 00810275013014 | K142113 | 000 |
| 00810275011065 | K142113 | 000 |