GlideScope BFlex Single-Use Bronchoscope System— 510(k) K183256

Substantially Equivalent

Verathon Medical (Canada) Ulc

FDA 510(k) clearance K183256 for GlideScope BFlex Single-Use Bronchoscope System, Substantially Equivalent on 2019-01-04. Applicant: Verathon Medical (Canada) Ulc.

Clearance details

Applicant: Verathon Medical (Canada) Ulc
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2018-11-21
Decision date: 2019-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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