Definition: To Dilate Esophageal Strictures With A Dilating Balloon And Electrode Sensors.
| Device Type ID | 2097 |
| Device Name | Esophageal Dilator With Balloon And Electrode Sensors |
| Physical State | Balloon With Electrode Sensors And Software |
| Technical Method | Balloon With Electrode Sensors |
| Target Area | Esophagus |
| Regulation Description | Gastrointestinal Tube 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 | 876.5980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2097 |
| Device | Esophageal Dilator With Balloon And Electrode Sensors |
| Product Code | PIE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CROSPON LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CROSPON, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
| Total Device Problems | 1 |