FDA Product Code
FDA Product Code FDX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | 2025-12-18 | Traditional | PDF ↗ |
| K220063 | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-07-28 | Traditional | PDF ↗ |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | 2019-11-14 | Special | PDF ↗ |
| K191485 | Deflectable Brush Biopsy Set | Cook Incorporated | 2019-06-26 | Traditional | PDF ↗ |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated | 2019-05-01 | Traditional | PDF ↗ |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2019-02-08 | Traditional | PDF ↗ |
| K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | 2018-03-05 | Traditional | PDF ↗ |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2017-12-29 | Traditional | PDF ↗ |
| K171607 | Bronchi and Gastrointestinal Cytology Brush | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-07-31 | Traditional | PDF ↗ |
| K151889 | Infinity ERCP Sampling Device | United States Endoscopy Group, Inc. | 2015-07-30 | Special | PDF ↗ |
| K103437 | US ENDOSCOPY CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | 2010-12-23 | Special | PDF ↗ |
| K052279 | COOK IRELAND ECHOBRUSH | Cook Ireland, Ltd. | 2005-10-11 | Traditional | PDF ↗ |
| K040324 | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | Wilson-Cook Medical, Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K021998 | HORIZONS CYTOLOGY BRUSH | Horizons Intl. Corp. | 2002-07-12 | Traditional | PDF ↗ |
| K965037 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1997-01-08 | Traditional | PDF ↗ |
| K960004 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K954121 | CYTOLOGY BRUSH | Lighthouse Medical, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K944614 | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | Biosearch Medical Products, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K942144 | URETHRA-BRUSH | Rovers Diagnostic Devices | 1994-06-27 | Traditional | PDF ↗ |
| K930348 | COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM | Boston Scientific Corp | 1993-09-03 | Traditional | PDF ↗ |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Intl. Medical, Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924104 | CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K922851 | CYTOLOGY BRUSH | Annex Medical, Inc. | 1992-08-25 | Traditional | PDF ↗ |
| K914504 | CYTOLOGY BRUSH | Surgitek Medical Engineering Corp. | 1992-02-18 | Traditional | PDF ↗ |
| K914466 | COX DISPOSABLE CYTOLOGY BRUSHES | Cox Medical Ent., Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K913248 | CYTOLOGY BRUSH | Annex Medical, Inc. | 1991-09-30 | Traditional | PDF ↗ |
| K912407 | COX DISPOSABLE CYTOLOGY BRUSHES | Cox Medical Ent., Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K911481 | LAPAROSCOPIC CLEANING BRUSH INSTRUMENT | United States Endoscopy Group, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K902737 | BC BRUSHES | Olympus Corp. | 1990-08-24 | Traditional | PDF ↗ |
| K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | Telemed Systems, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K901436 | BRONCHIAL CYTOLOGY BRUSH | Telemed Systems, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K896318 | WILSON-COOK CYTOLOGY BRUSHES | Wilson-Cook Medical, Inc. | 1990-04-09 | Traditional | PDF ↗ |
| K896425 | PORGES CYTOLOGY BRUSHES | Porges Corp. | 1990-01-29 | Traditional | PDF ↗ |
| K894863 | WILTEK CYTOLOGY BRUSH | Wiltek Medical, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | Hobbs Medical, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | Van-Tec, Inc. | 1988-03-02 | Traditional | PDF ↗ |
| K860997 | GASTROINTESTINAL CYTOLOGY BRUSH | Endovations | 1986-05-02 | Traditional | PDF ↗ |
| K853530 | ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH | E-Z-Em, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K844561 | BARD URETEROSCOPIC CYTOLOGY BRUSH | C.R. Bard, Inc. | 1985-01-08 | Traditional | PDF ↗ |
| K834402 | GASTROINTESTINAL SHEATH BRUSH | Hobbs Medical, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833330 | MUTO BRUSH | Microvasive | 1983-11-14 | Traditional | PDF ↗ |
| K800966 | M.R. ASSOC. CYTOLOGY BRUSHES | Mr Associates, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K791668 | ENDOSCOPIC CYTOLOGY BRUSHES | Mill-Rose Laboratory | 1979-10-01 | Traditional | PDF ↗ |
| K770913 | UROLOGICAL BIOPSY BRUSH SET | Cook, Inc. | 1977-06-01 | Traditional | PDF ↗ |
Product code FDX · Class II · Gastroenterology, Urology. Data: openFDA.