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Bronchoscope (Flexible Or Rigid)

FDA product code EOQ · 235 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.4680
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1976-07-19 – 2026-09-23

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).

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