GlideScope BFlex 5.8 Single-Use Bronchoscope— 510(k) K191948

Name: FDA 510(k) clearance K191948
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

Substantially Equivalent

Verathon Medical (Canada) Ulc

FDA 510(k) clearance K191948 for GlideScope BFlex 5.8 Single-Use Bronchoscope, Substantially Equivalent on 2019-08-21. Applicant: Verathon Medical (Canada) Ulc. Device class: 2.

Clearance details

Applicant: Verathon Medical (Canada) Ulc
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2019-07-22
Decision date: 2019-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Verathon Medical (Canada) Ulc

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K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 more2026-05-11
K230948 — BFlex 2 Slim 3.8 Single-Use Bronchoscope2023-05-03
K211947 — GlideScope BFlex 2.8 Single-Use Bronchoscope2021-11-03
K193488 — GlideScope BFlex 3.8 Single-Use Bronchoscope2020-01-16
K183256 — GlideScope BFlex Single-Use Bronchoscope System2019-01-04

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.