Definition: To Dilate The Lower Esophageal Sphincter Of Patients With Achalasia.
| Device Type ID | 2096 |
| Device Name | Esophageal Dilator Balloon With Or Without Electrode Sensors |
| Physical State | Tube And Balloon With Or Without Electrode Sensors And Software. |
| Technical Method | Tube And Balloon With Or Without Electrode Sensors. |
| Target Area | Lower Esophageal Sphincter |
| 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 | PID |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2096 |
| Device | Esophageal Dilator Balloon With Or Without Electrode Sensors |
| Product Code | PID |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |