EOQ

241 FDA 510(k) clearances · Product code

FDA profile

Official device name

Bronchoscope (Flexible Or Rigid)

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4680

Medical specialty

Ear, Nose, Throat

FDA 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 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)

2021: 1,358 · 2022: 2,541 · 2023: 5,064 · 2024: 6,051 · 2025: 6,619 · 2026: 6,350
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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