Product code FDX— Gastroenterology, Urology
CYTOLOGY BRUSH
- Classification name
- Endoscopic Cytology Brush
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 44
- First cleared
- Most recent
FDA classification definition
“To collect cells for cytological evaluation.”
Market context for product code FDX
FDA has cleared devices under product code FDX between 1977 and 2025, filed by 31 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2022
- 2019
- 2018
- 2017
- 2015
- 2010
- 2005
- 2004
- 2002
- 1997
- 1996
- 1995
- 1994
- 1993
Top applicants under product code FDX
Recent clearances under product code FDX
- K250993 — Single Use Cytology Brush V (BC-V600P-3010)
- K220063 — Single Use Cytology Brush
- K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
- K191485 — Deflectable Brush Biopsy Set
- K182231 — Brush Biopsy Set; Deflectable Brush Biopsy Set
- K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K172663 — Cytology Brush
- K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K171607 — Bronchi and Gastrointestinal Cytology Brush
- K151889 — Infinity ERCP Sampling Device
- K103437 — US ENDOSCOPY CYTOLOGY BRUSH
- K052279 — COOK IRELAND ECHOBRUSH
- K040324 — WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
- K021998 — HORIZONS CYTOLOGY BRUSH
- K965037 — CELL RECOVERY SYSTEM
- K960004 — CELL RECOVERY SYSTEM
- K954121 — CYTOLOGY BRUSH
- K944614 — MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
- K942144 — URETHRA-BRUSH
- K930348 — COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
- K923200 — AMCATH DISPOSABLE CYTOLOGY BRUSH
- K924104 — CYTOLOGY BRUSH
- K922851 — CYTOLOGY BRUSH
- K914504 — CYTOLOGY BRUSH
- K914466 — COX DISPOSABLE CYTOLOGY BRUSHES
- K913248 — CYTOLOGY BRUSH
- K912407 — COX DISPOSABLE CYTOLOGY BRUSHES
- K911481 — LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
- K902737 — BC BRUSHES
- K901435 — GASTROINTESTINAL CYTOLOGY BRUSH
- K901436 — BRONCHIAL CYTOLOGY BRUSH
- K896318 — WILSON-COOK CYTOLOGY BRUSHES
- K896425 — PORGES CYTOLOGY BRUSHES
- K894863 — WILTEK CYTOLOGY BRUSH
- K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH
- K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH
- K860997 — GASTROINTESTINAL CYTOLOGY BRUSH
- K853530 — ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
- K844561 — BARD URETEROSCOPIC CYTOLOGY BRUSH
- K834402 — GASTROINTESTINAL SHEATH BRUSH
- K833330 — MUTO BRUSH
- K800966 — M.R. ASSOC. CYTOLOGY BRUSHES
- K791668 — ENDOSCOPIC CYTOLOGY BRUSHES
- K770913 — UROLOGICAL BIOPSY BRUSH SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.