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Panels › Gastroenterology, Urology › Product code FDX · Class 2

Endoscopic Cytology Brush

Regulation 876.1500

1510(k)s in 12 months (44 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
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Top companies in FDX

Company510(k)sRecalls
Hobbs Medical, Inc.24
Wilson-Cook Medical, Inc.50
United States Endoscopy Group, Inc.40
Cook Incorporated30
Annex Medical, Inc.20
Cox Medical Ent., Inc.20
Medical Device Technologies, Inc.20
Telemed Systems, Inc.20
Biosearch Medical Products, Inc.10
Boston Scientific Corp10
Decided510(k)Device and applicantCode
Dec 18, 2025K250993Single Use Cytology Brush V (BC-V600P-3010)
Olympus Medical Systems Corporation, JP
FDX
Jul 28, 2022K220063Single Use Cytology Brush
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
FDX
Nov 14, 2019K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
Wilson-Cook Medical, Inc.
FDX
Jun 26, 2019K191485Deflectable Brush Biopsy Set
Cook Incorporated
FDX
May 1, 2019K182231Brush Biopsy Set ; Deflectable Brush Biopsy Set
Cook Incorporated
FDX
Feb 8, 2019K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Wilson-Cook Medical, Inc.
FDX
Mar 5, 2018K172663Cytology Brush
Micro-Tech (Nanjing) Co., Ltd., CN
FDX
Dec 29, 2017K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Wilson-Cook Medical, Inc.
FDX
Jul 31, 2017K171607Bronchi and Gastrointestinal Cytology Brush
Wilson-Cook Medical Inc./Cook Endoscopy
FDX
Jul 30, 2015K151889Infinity ERCP Sampling Device
United States Endoscopy Group, Inc.
FDX
Dec 23, 2010K103437US ENDOSCOPY CYTOLOGY BRUSH
United States Endoscopy Group, Inc.
FDX
Oct 11, 2005K052279COOK IRELAND ECHOBRUSH
Cook Ireland, Ltd., IE
FDX
May 20, 2004K040324WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
Wilson-Cook Medical, Inc.
FDX
Jul 12, 2002K021998HORIZONS CYTOLOGY BRUSH
Horizons Intl. Corp.
FDX
Jan 8, 1997K965037CELL RECOVERY SYSTEM
Medical Device Technologies, Inc.
FDX
Mar 20, 1996K960004CELL RECOVERY SYSTEM
Medical Device Technologies, Inc.
FDX
Oct 7, 1995K954121CYTOLOGY BRUSH
Lighthouse Medical, Inc.
FDX
Apr 5, 1995K944614MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
Biosearch Medical Products, Inc.
FDX
Jun 27, 1994K942144URETHRA-BRUSH
Rovers Diagnostic Devices
FDX
Sep 3, 1993K930348COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
Boston Scientific Corp
FDX
Dec 7, 1992K923200AMCATH DISPOSABLE CYTOLOGY BRUSH
Intl. Medical, Inc.
FDX
Nov 24, 1992K924104CYTOLOGY BRUSH
United States Endoscopy Group, Inc.
FDX
Aug 25, 1992K922851CYTOLOGY BRUSH
Annex Medical, Inc.
FDX
Feb 18, 1992K914504CYTOLOGY BRUSH
Surgitek Medical Engineering Corp.
FDX
Oct 25, 1991K914466COX DISPOSABLE CYTOLOGY BRUSHES
Cox Medical Ent., Inc.
FDX
Sep 30, 1991K913248CYTOLOGY BRUSH
Annex Medical, Inc.
FDX
Sep 10, 1991K912407COX DISPOSABLE CYTOLOGY BRUSHES
Cox Medical Ent., Inc.
FDX
Apr 22, 1991K911481LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
United States Endoscopy Group, Inc.
FDX
Aug 24, 1990K902737BC BRUSHES
Olympus Corp.
FDX
Jul 16, 1990K901435GASTROINTESTINAL CYTOLOGY BRUSH
Telemed Systems, Inc.
FDX
Jun 18, 1990K901436BRONCHIAL CYTOLOGY BRUSH
Telemed Systems, Inc.
FDX
Apr 9, 1990K896318WILSON-COOK CYTOLOGY BRUSHES
Wilson-Cook Medical, Inc.
FDX
Jan 29, 1990K896425PORGES CYTOLOGY BRUSHES
Porges Corp.
FDX
Dec 21, 1989K894863WILTEK CYTOLOGY BRUSH
Wiltek Medical, Inc.
FDX
Aug 28, 1989K893729HOBBS MEDICAL MICROBIOLOGY BRUSH
Hobbs Medical, Inc.
FDX
Mar 2, 1988K880095BERGER PROSTATE CULTURE CYTOLOGY BRUSH
Van-Tec, Inc.
FDX
May 2, 1986K860997GASTROINTESTINAL CYTOLOGY BRUSH
Endovations
FDX
Oct 4, 1985K853530ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
E-Z-Em, Inc.
FDX
Jan 8, 1985K844561BARD URETEROSCOPIC CYTOLOGY BRUSH
C.R. Bard, Inc.
FDX
Feb 4, 1984K834402GASTROINTESTINAL SHEATH BRUSH
Hobbs Medical, Inc.
FDX
Nov 14, 1983K833330MUTO BRUSH
Microvasive
FDX
May 8, 1980K800966M.R. ASSOC. CYTOLOGY BRUSHES
Mr Associates, Inc.
FDX
Oct 1, 1979K791668ENDOSCOPIC CYTOLOGY BRUSHES
Mill-Rose Laboratory
FDX
Jun 1, 1977K770913UROLOGICAL BIOPSY BRUSH SET
Cook, Inc.
FDX

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