PID — Esophageal Dilator Balloon With Or Without Electrode Sensors Class II
FDA product code PID covers "Esophageal Dilator Balloon With Or Without Electrode Sensors", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PID
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To dilate the lower esophageal sphincter of patients with Achalasia.