Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GlideScope BFlex 3.8 Single-Use Bronchoscope

K-Number: K193488 · 2020-01-16

ApplicantVerathon Medical (Canada) Ulc
Decision Date2020-01-16
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GlideScope BFlex 3.8 Single-Use Bronchoscope is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Medical (Canada) Ulc. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K193488. 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 3.8 Single-Use Bronchoscope?

GlideScope BFlex 3.8 Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Verathon Medical (Canada) Ulc. The 510(k) number is K193488.

When did GlideScope BFlex 3.8 Single-Use Bronchoscope receive FDA 510(k) clearance?

GlideScope BFlex 3.8 Single-Use Bronchoscope received FDA 510(k) clearance on 2020-01-16, under 510(k) number K193488.

Who is the listed applicant for GlideScope BFlex 3.8 Single-Use Bronchoscope?

The FDA 510(k) record lists Verathon Medical (Canada) Ulc as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Verathon Medical (Canada) Ulc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)K230948BFlex™ 2 Slim 3.8 Single-Use BronchoscopeK211947GlideScope BFlex 2.8 Single-Use BronchoscopeK191948GlideScope BFlex 5.8 Single-Use BronchoscopeK183256GlideScope BFlex Single-Use Bronchoscope System

Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

Official Source

View on FDA Database →

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

↑