Product code
PLA: Esophageal thermal regulation and gastric suctioning device
FDA product code · Class II · Cardiovascular
Key facts
| Product code | PLA |
|---|---|
| Device | Esophageal thermal regulation and gastric suctioning device |
| Device class | Class II |
| Regulation number | 870.5910 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage. |
At a glance
- 1–9 510(k) clearances
- 1–9 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