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FDA 510(k)

GlideScope BFlex 5.8 Single-Use Bronchoscope

K-Number: K191948 · 2019-08-21

ApplicantVerathon Medical (Canada) Ulc
Decision Date2019-08-21
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GlideScope BFlex 5.8 Single-Use Bronchoscope is a medical device manufactured by Verathon Medical (Canada) Ulc. It received FDA 510(k) clearance on 2019-08-21 under approval number K191948. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GlideScope BFlex 5.8 Single-Use Bronchoscope?

GlideScope BFlex 5.8 Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2019-08-21. It is manufactured by Verathon Medical (Canada) Ulc. The 510(k) number is K191948.

When was GlideScope BFlex 5.8 Single-Use Bronchoscope approved by the FDA?

GlideScope BFlex 5.8 Single-Use Bronchoscope received FDA 510(k) clearance on 2019-08-21, under approval number K191948.

What company makes GlideScope BFlex 5.8 Single-Use Bronchoscope?

GlideScope BFlex 5.8 Single-Use Bronchoscope is manufactured by Verathon Medical (Canada) Ulc.

What is the FDA product code for GlideScope BFlex 5.8 Single-Use Bronchoscope?

The FDA product code for GlideScope BFlex 5.8 Single-Use Bronchoscope is EOQ.

Other Devices by Verathon Medical (Canada) Ulc

K183256GlideScope BFlex Single-Use Bronchoscope System K193488GlideScope BFlex 3.8 Single-Use Bronchoscope K211947GlideScope BFlex 2.8 Single-Use Bronchoscope K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)

Related Devices (Code: EOQ)

K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView MonitorAmbu A/S K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc. K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)Prosurg, Inc. K171492B7 2C Occlusion BalloonSpiration, Inc. K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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