Atlas FDA

FDX

44 FDA 510(k) clearances · Product code

70 daysmedian time to decision
213 days90th percentile
44clearances measured

FDA profile

Official device name
Endoscopic Cytology Brush
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
FDA definition
To collect cells for cytological evaluation.
Adverse events (MAUDE)
2019: 67 · 2020: 13 · 2021: 19 · 2022: 17 · 2023: 17 · 2024: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Single Use Cytology Brush V (BC-V600P-3010) (K250993)Olympus Medical Systems Corporation2025-12-18
Single Use Cytology Brush (K220063)Zhejiang Chuangxiang Medical Technology Co., Ltd.2022-07-28
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (K192908)Wilson-Cook Medical, Inc.2019-11-14
Deflectable Brush Biopsy Set (K191485)Cook Incorporated2019-06-26
Brush Biopsy Set ; Deflectable Brush Biopsy Set (K182231)Cook Incorporated2019-05-01
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K181317)Wilson-Cook Medical, Inc.2019-02-08
Cytology Brush (K172663)Micro-Tech (Nanjing) Co., Ltd.2018-03-05
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K171573)Wilson-Cook Medical, Inc.2017-12-29
Bronchi and Gastrointestinal Cytology Brush (K171607)Wilson-Cook Medical Inc./Cook Endoscopy2017-07-31
Infinity ERCP Sampling Device (K151889)United States Endoscopy Group, Inc.2015-07-30
US ENDOSCOPY CYTOLOGY BRUSH (K103437)United States Endoscopy Group, Inc.2010-12-23
COOK IRELAND ECHOBRUSH (K052279)Cook Ireland, Ltd.2005-10-11
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH (K040324)Wilson-Cook Medical, Inc.2004-05-20
HORIZONS CYTOLOGY BRUSH (K021998)Horizons Intl. Corp.2002-07-12
CELL RECOVERY SYSTEM (K965037)Medical Device Technologies, Inc.1997-01-08
CELL RECOVERY SYSTEM (K960004)Medical Device Technologies, Inc.1996-03-20
CYTOLOGY BRUSH (K954121)Lighthouse Medical, Inc.1995-10-07
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM (K944614)Biosearch Medical Products, Inc.1995-04-05
URETHRA-BRUSH (K942144)Rovers Diagnostic Devices1994-06-27
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM (K930348)Boston Scientific Corp1993-09-03
AMCATH DISPOSABLE CYTOLOGY BRUSH (K923200)Intl. Medical, Inc.1992-12-07
CYTOLOGY BRUSH (K924104)United States Endoscopy Group, Inc.1992-11-24
CYTOLOGY BRUSH (K922851)Annex Medical, Inc.1992-08-25
CYTOLOGY BRUSH (K914504)Surgitek Medical Engineering Corp.1992-02-18
COX DISPOSABLE CYTOLOGY BRUSHES (K914466)Cox Medical Ent., Inc.1991-10-25
CYTOLOGY BRUSH (K913248)Annex Medical, Inc.1991-09-30
COX DISPOSABLE CYTOLOGY BRUSHES (K912407)Cox Medical Ent., Inc.1991-09-10
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT (K911481)United States Endoscopy Group, Inc.1991-04-22
BC BRUSHES (K902737)Olympus Corp.1990-08-24
GASTROINTESTINAL CYTOLOGY BRUSH (K901435)Telemed Systems, Inc.1990-07-16
BRONCHIAL CYTOLOGY BRUSH (K901436)Telemed Systems, Inc.1990-06-18
WILSON-COOK CYTOLOGY BRUSHES (K896318)Wilson-Cook Medical, Inc.1990-04-09
PORGES CYTOLOGY BRUSHES (K896425)Porges Corp.1990-01-29
WILTEK CYTOLOGY BRUSH (K894863)Wiltek Medical, Inc.1989-12-21
HOBBS MEDICAL MICROBIOLOGY BRUSH (K893729)Hobbs Medical, Inc.1989-08-28
BERGER PROSTATE CULTURE CYTOLOGY BRUSH (K880095)Van-Tec, Inc.1988-03-02
GASTROINTESTINAL CYTOLOGY BRUSH (K860997)Endovations1986-05-02
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH (K853530)E-Z-Em, Inc.1985-10-04
BARD URETEROSCOPIC CYTOLOGY BRUSH (K844561)C.R. Bard, Inc.1985-01-08
GASTROINTESTINAL SHEATH BRUSH (K834402)Hobbs Medical, Inc.1984-02-04
MUTO BRUSH (K833330)Microvasive1983-11-14
M.R. ASSOC. CYTOLOGY BRUSHES (K800966)Mr Associates, Inc.1980-05-08
ENDOSCOPIC CYTOLOGY BRUSHES (K791668)Mill-Rose Laboratory1979-10-01
UROLOGICAL BIOPSY BRUSH SET (K770913)Cook, Inc.1977-06-01

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