Product code
MWM: Sensor, electro-optical (for cervical cancer)
FDA product code · Class III · Obstetrics/Gynecology
Key facts
| Product code | MWM |
|---|---|
| Device | Sensor, electro-optical (for cervical cancer) |
| Device class | Class III |
| Review panel | Obstetrics/Gynecology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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