PID
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Esophageal Dilator Balloon With Or Without Electrode Sensors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To dilate the lower esophageal sphincter of patients with Achalasia.
- Adverse events (MAUDE)
- 2024: 83 · 2025: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Wilson-Cook Achalasia Balloon (K182895) | Wilson-Cook Medical, Inc. | 2019-01-25 |
| ESOFLIP BALLOON DILATION CATHETER (K132337) | Crospon, Ltd. | 2013-10-07 |
| RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR (K050232) | Boston Scientific Corp | 2005-03-11 |
Track PID automatically
Every clearance here is in the API, with alerts when new ones post.