ENZ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Telescope, Laryngeal-Bronchial

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4680

Medical specialty

Ear, Nose, Throat

Flags

Third-party review eligible

FDA 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).

Adverse events (MAUDE)

2000: 1 · 2001: 3 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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