Endoscopic Cytology Brush
Gastroenterology, Urology · 21 CFR 876.1500
To collect cells for cytological evaluation.
Recent MDR events
695 adverse event reports on file
- SUPERDIMENSION CYTOLOGY BRUSHJul 17, 2026InjuryHobbs Medical1220592-2026-00002
- RX Cytology BrushJul 3, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02666
- UNKNOWN CYTOLOGY BRUSHJun 4, 2026InjuryCovidien Lp - Superdimension Inc3004962788-2026-00041
- RX CYTOLOGY BRUSHMay 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02170
- RX CYTOLOGY BRUSHMay 7, 2026MalfunctionBoston Scientific Corporation3005099803-2026-01672
- CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHApr 13, 2026InjuryWilson-cook Medical Inc (cook Endoscopy)1037905-2026-00175
- CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHApr 13, 2026InjuryWilson-cook Medical Inc (cook Endoscopy)1037905-2026-00174
- RX CYTOLOGY BRUSHApr 1, 2026InjuryBoston Scientific Corporation3005099803-2026-01180
- FUSION CYTOLOGY BRUSHMar 23, 2026MalfunctionWilson-cook Medical Inc (cook Endoscopy)1037905-2026-00138
- CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHDec 22, 2025MalfunctionWilson-cook Medical Inc (cook Endoscopy)1037905-2025-00858
Event type breakdown
Recalls
5 recall events for this product code
- Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Medical Cytology Brush
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0013-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Medical Cytology Brush
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0014-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedMar 2, 2022
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brus
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
Z-0711-2022 · View FDA record ↗ - Ekos CorpTerminatedNov 16, 2006
Lysus Transport Stand (infusion stand), part number 4896-003
Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
Z-0195-2007 · View FDA record ↗ - Hobbs Medical, Inc.TerminatedUnknown
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206
Device was marketed for uses outside the 510(k) clearance.
Z-2052-2018 · View FDA record ↗
Registered firms
68 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Isomedix Operations Inc.
S Plainfield, NJ, US
United States Endoscopy Group, Inc.
Mentor, OH, US
Avanos Medical, Inc.
Alpharetta, GA, US
Conmed Corporation
WESTBOROUGH, MA, US
Cook Incorporated
ELLETTSVILLE, IN, US
Cook Incorporated
Spencer, IN, US
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Conmed Corporation
Utica, NY, US
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Annex Medical, Inc.
Minnetonka, MN, US
Lynx Medical Pennsylvania
ERIE, PA, US
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Aomori Olympus Co., Ltd. Hirosaki Site
Hirosaki-shi Aomori, JP
Sterigenics U.s., Llc
Santa Teresa, NM, US
Boston Scientific Corporation
Marlborough, MA, US
Isomedix Operations Inc.
Northborough, MA, US
Micro-tech (nanjing) Co., Ltd.
Nanjing Jiangsu, CN
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Cook Incorporated
Bloomington, IN, US
510(k) clearances
44 clearances for this product code
- Olympus Medical Systems CorporationDec 18, 2025
K250993 · Single Use Cytology Brush V (BC-V600P-3010)
- Zhejiang Chuangxiang Medical Technology Co., Ltd.Jul 28, 2022
K220063 · Single Use Cytology Brush
- Wilson-Cook Medical, Inc.Nov 14, 2019
K192908 · Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
- Cook IncorporatedJun 26, 2019
K191485 · Deflectable Brush Biopsy Set
- Cook IncorporatedMay 1, 2019
K182231 · Brush Biopsy Set ; Deflectable Brush Biopsy Set
- Wilson-Cook Medical, Inc.Feb 8, 2019
K181317 · Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- Micro-Tech (Nanjing) Co., Ltd.Mar 5, 2018
K172663 · Cytology Brush
- Wilson-Cook Medical, Inc.Dec 29, 2017
K171573 · Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush