ENZ
- Product code
- ENZ
- Device name
- Telescope, Laryngeal-Bronchial
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Official FDA classification page: ENZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).