FDA 510(k)

GlideScope BFlex Single-Use Bronchoscope System

Número K: K183256 · 2019-01-04

Data da decisão2019-01-04

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

GlideScope BFlex Single-Use Bronchoscope System 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 2019-01-04 under 510(k) number K183256. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GlideScope BFlex Single-Use Bronchoscope System?

GlideScope BFlex Single-Use Bronchoscope System is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Verathon Medical (Canada) Ulc. The 510(k) number is K183256.

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

GlideScope BFlex Single-Use Bronchoscope System received FDA 510(k) clearance on 2019-01-04, under 510(k) number K183256.

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

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 Single-Use Bronchoscope System?

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

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Verathon Medical (Canada) Ulc como candidato(a)

K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope K211947GlideScope BFlex 2.8 Single-Use Bronchoscope K193488GlideScope BFlex 3.8 Single-Use Bronchoscope K191948GlideScope BFlex 5.8 Single-Use Bronchoscope

Dispositivos Relacionados (Código: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.