Product code
EOQ: Bronchoscope (flexible or rigid)
FDA product code · Class II · Ear Nose & Throat
Key facts
| Product code | EOQ |
|---|---|
| Device | Bronchoscope (flexible or rigid) |
| Device class | Class II |
| Regulation number | 874.4680 |
| Review panel | Ear Nose & Throat |
| Medical specialty | Ear Nose & Throat |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing… |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 100–999 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