ENZ

Telescope, Laryngeal-Bronchial

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ENZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).