Product code
NKA: System, documentation, breast lesion
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | NKA |
|---|---|
| Device | System, documentation, breast lesion |
| Device class | Class II |
| Regulation number | 884.2990 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam. |
At a glance
- 1–9 510(k) clearances
- 1–9 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