Product code
HDT: Device, intrauterine, contraceptive and introducer
FDA product code · Class III · Obstetrics/Gynecology
Key facts
| Product code | HDT |
|---|---|
| Device | Device, intrauterine, contraceptive and introducer |
| Device class | Class III |
| Regulation number | 884.5360 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86 |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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