PIE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Esophageal Dilator With Balloon And Electrode Sensors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To dilate esophageal strictures with a dilating balloon and electrode sensors.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EsoFLIP® ES-310 Balloon Catheter (K172128) | Crospon, Ltd. | 2017-11-22 |
| ESOFLIP ES (K142000) | Crospon, Ltd. | 2014-09-25 |
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Every clearance here is in the API, with alerts when new ones post.