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FDX — Endoscopic Cytology Brush Class II

FDA Device Classification

Classification Details

Product Code
FDX
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To collect cells for cytological evaluation.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250993olympus medical systems corporationSingle Use Cytology Brush V (BC-V600P-3010)December 18, 2025
K220063zhejiang chuangxiang medical technology coSingle Use Cytology BrushJuly 28, 2022
K192908wilson-cook medicalFusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesNovember 14, 2019
K191485cook incorporatedDeflectable Brush Biopsy SetJune 26, 2019
K182231cook incorporatedBrush Biopsy Set ; Deflectable Brush Biopsy SetMay 1, 2019
K181317wilson-cook medicalFusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFebruary 8, 2019
K172663micro-tech (nanjing) coCytology BrushMarch 5, 2018
K171573wilson-cook medicalFusion Cytology Brush, CytoMax II Double Lumen Cytology BrushDecember 29, 2017
K171607wilson-cook medical inc./cook endoscopyBronchi and Gastrointestinal Cytology BrushJuly 31, 2017
K151889united states endoscopy groupInfinity ERCP Sampling DeviceJuly 30, 2015
K103437united states endoscopy groupUS ENDOSCOPY CYTOLOGY BRUSHDecember 23, 2010
K052279cook irelandCOOK IRELAND ECHOBRUSHOctober 11, 2005
K040324wilson-cook medicalWILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSHMay 20, 2004
K021998horizons intlHORIZONS CYTOLOGY BRUSHJuly 12, 2002
K965037medical device technologiesCELL RECOVERY SYSTEMJanuary 8, 1997
K960004medical device technologiesCELL RECOVERY SYSTEMMarch 20, 1996
K954121lighthouse medicalCYTOLOGY BRUSHOctober 7, 1995
K944614biosearch medical productsMEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEMApril 5, 1995
K942144rovers diagnostic devicesURETHRA-BRUSHJune 27, 1994
K930348boston scientificCOMBO CATH WIRE-GUIDED CYTOLOGY SYSTEMSeptember 3, 1993