Cox Disposable Cytology Brushes
FDA 510(k) K914466 · Cox Medical Ent., Inc.
510(k) numberK914466
Submission
- Device name
- Cox Disposable Cytology Brushes
- Applicant
- Cox Medical Ent., Inc.
Ventura, CA, US - Received
- October 7, 1991
- Decision date
- October 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FDX – Endoscopic Cytology Brush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To collect cells for cytological evaluation.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010)FDX · Traditional | Olympus Medical Systems Corporation | 12/18/2025SE |
| K220063 | Single Use Cytology BrushFDX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 07/28/2022SE |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesFDX · Special | Wilson-Cook Medical, Inc. | 11/14/2019SE |
| K191485 | Deflectable Brush Biopsy SetFDX · Traditional | Cook Incorporated | 06/26/2019SE |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy SetFDX · Traditional | Cook Incorporated | 05/01/2019SE |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFDX · Traditional | Wilson-Cook Medical, Inc. | 02/08/2019SE |
| K172663 | Cytology BrushFDX · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 03/05/2018SE |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFDX · Traditional | Wilson-Cook Medical, Inc. | 12/29/2017SE |
| K171607 | Bronchi and Gastrointestinal Cytology BrushFDX · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 07/31/2017SE |
| K151889 | Infinity ERCP Sampling DeviceFDX · Special | United States Endoscopy Group, Inc. | 07/30/2015SE |
More from United States Endoscopy Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950689 | UcbMNL · Traditional | 03/06/1995SE |
| K946360 | Modular Biopsy ForcepFCL · Traditional | 03/06/1995SE |
| K941464 | Basics Endoscopy SystemOCZ · Traditional | 08/05/1994SE |
| K940911 | Basics Endoscopy SystemKGE · Traditional | 05/16/1994SE |
| K932790 | Thermal OptionKGE · Traditional | 01/28/1994SE |
| K935250 | Accu-PathFCL · Traditional | 01/21/1994SE |
| K924655 | Cox Disposable Endoscope Cleaning BRUSH(CB-X2)FEB · Traditional | 12/15/1992SE |
| K923671 | Cox Disposable Polypectomy SnaresFDI · Traditional | 10/13/1992SE |
| K923672 | Cox Disposable Endoscope Cleaning BrushFEB · Traditional | 09/23/1992SE |
| K923489 | Cox Disposable Retrieval DevicesOCZ · Traditional | 09/23/1992SE |
Questions and answers
When was Cox Disposable Cytology Brushes cleared by the FDA?
Cox Disposable Cytology Brushes (K914466) received a 510(k) decision of Substantially Equivalent on October 25, 1991, 18 days after the submission was received.
What is the product code of K914466?
The FDA product code is FDX – Endoscopic Cytology Brush, a Class II (moderate risk) device regulated under 21 CFR 876.1500.