Product code
FBY: Cooler, esophageal and gastric
FDA product code · Class III · Gastroenterology/Urology
Key facts
| Product code | FBY |
|---|---|
| Device | Cooler, esophageal and gastric |
| Device class | Class III |
| Review panel | Gastroenterology/Urology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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