DeviceClearance

Product code ENZ— Ear, Nose, Throat

DUALUME LARYNGEAL EXAMINATION TELESCOPE

Classification name
Telescope, Laryngeal-Bronchial
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Total cleared
3
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code ENZ under 21 CFR 874.4680, via openFDA

Market context for product code ENZ

FDA has cleared 3 devices under product code ENZ between 1979 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ENZ

Recent clearances under product code ENZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.