Definition: To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (GERD), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant.
| Device Type ID | 2072 |
| Device Name | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Physical State | May Include: Capsule Assembly, Needle Assembly, Guidewire, Suture Cutter, Tubing, Clip Delivery Device, Clips Or Other Implant, Plication Instrument, Overtube, Retractor |
| Technical Method | Place Sutures In Soft Tissue Of Stomach And Esophagus, Or Deliver Implant In Stomach Near Gastroesophageal Junction |
| Target Area | Gastroesophageal Junction GEJ |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2072 |
| Device | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Product Code | ODE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENDOGASTRIC SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDIGUS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDIGUS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 14 |
Use Of Device Problem | 2 |
Device Operates Differently Than Expected | 1 |
Device Issue | 1 |
Insufficient Information | 1 |
| Total Device Problems | 19 |