Product code PID
- Device name
- Esophageal Dilator Balloon With Or Without Electrode Sensors
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To dilate the lower esophageal sphincter of patients with Achalasia.
- Source
- FDA openFDA device classification dataset