Product code
PIE: Esophageal dilator with balloon and electrode sensors
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | PIE |
|---|---|
| Device | Esophageal dilator with balloon and electrode sensors |
| Device class | Class II |
| Regulation number | 876.5980 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To dilate esophageal strictures with a dilating balloon and electrode sensors. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database