FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

Número K: K192908 · 2019-11-14

Data da decisão2019-11-14

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-11-14 under 510(k) number K192908. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K192908.

When did Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes receive FDA 510(k) clearance?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes received FDA 510(k) clearance on 2019-11-14, under 510(k) number K192908.

Who is the listed applicant for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

The FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is FDX.

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 Wilson-Cook Medical, Inc. como candidato(a)

K253302Hemospray Endoscopic Hemostat (HEMO-[X])K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord K213356Entuit PEG, Entuit PEGJ K212323Instinct Plus Endoscopic Clipping Device K201322Entuit Nasal Jejunal Feeding Tube K200972Hemospray Endoscopic Hemostat

Ver todos os 32 dispositivos →

Dispositivos Relacionados (Código: FDX)

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K191485Deflectable Brush Biopsy SetCook Incorporated K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.

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.