FDA 510(k)

BFlex 2 Slim 3.8 Single-Use Bronchoscope

K-Number: K230948 · 2023-05-03

Decision Date2023-05-03

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BFlex 2 Slim 3.8 Single-Use Bronchoscope is a medical device manufactured by Verathon Medical (Canada) Ulc. It received FDA 510(k) clearance on 2023-05-03 under approval number K230948. 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 BFlex 2 Slim 3.8 Single-Use Bronchoscope?

BFlex 2 Slim 3.8 Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2023-05-03. It is manufactured by Verathon Medical (Canada) Ulc. The 510(k) number is K230948.

When was BFlex 2 Slim 3.8 Single-Use Bronchoscope approved by the FDA?

BFlex 2 Slim 3.8 Single-Use Bronchoscope received FDA 510(k) clearance on 2023-05-03, under approval number K230948.

What company makes BFlex 2 Slim 3.8 Single-Use Bronchoscope?

BFlex 2 Slim 3.8 Single-Use Bronchoscope is manufactured by Verathon Medical (Canada) Ulc.

What is the FDA product code for BFlex 2 Slim 3.8 Single-Use Bronchoscope?

The FDA product code for BFlex 2 Slim 3.8 Single-Use Bronchoscope is EOQ.

Other Devices by Verathon Medical (Canada) Ulc

K191948GlideScope BFlex 5.8 Single-Use Bronchoscope K183256GlideScope BFlex Single-Use Bronchoscope System K193488GlideScope BFlex 3.8 Single-Use Bronchoscope K211947GlideScope BFlex 2.8 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.