EOQClass II

Bronchoscope (flexible Or Rigid)

Ear, Nose, Throat · 21 CFR 874.4680

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).

MDR events31,113All time

Recalls160All time

Registered firms647Currently listed

510(k) clearances241All time

Recent MDR events

31,113 adverse event reports on file

Event type breakdown

Malfunction26,649

Injury4,150

Death204

Other96

Unspecified14

Most-reported manufacturers

Aizu Olympus Co., Ltd.20,607 Olympus Medical Systems Corp.2,915 Hoya Corporation Pentax Tokyo Office2,703 Intuitive Surgical, Inc1,707 Boston Scientific Corporation369 Olympus Medical Systems Corp. Hinode Plant252 Boston Scientific - Spencer230 Auris Health, Inc.223

Recalls

160 recall events for this product code

Registered firms

647 firms currently registered for this product code

510(k) clearances

241 clearances for this product code