Amcath Disposable Cytology Brush
FDA 510(k) K923200 · Intl. Medical, Inc.
510(k) numberK923200
Submission
- Device name
- Amcath Disposable Cytology Brush
- Applicant
- Intl. Medical, Inc.
Danielson, CT, US - Received
- June 30, 1992
- Decision date
- December 7, 1992
- 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.
Other 510(k)s with product code FDX
| 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 |
|---|---|---|
| K970507 | Peak Flow MeterBZH · Traditional | 06/13/1997SE |
| K943078 | Hot Biopsy ForcepsKGE · Traditional | 11/14/1994SE |
| K940370 | American Catheter E.R.C.P. CannulaFGE · Traditional | 08/17/1994SE |
| K940335 | American Catheter Poly-SnareFDI · Traditional | 07/21/1994SE |
| K942068 | American Catheter SphincterotomeKNS · Traditional | 06/24/1994SE |
| K930410 | Durham; Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K930406 | Durham; Min Bore Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | 01/10/1992SE |
| K912927 | Amcath Disposable Trocar and Trocar SleeveGCJ · Traditional | 09/19/1991SE |
| K912605 | Amcath Disposable Micro ScissorsGCJ · Traditional | 07/11/1991SE |
Questions and answers
When was Amcath Disposable Cytology Brush cleared by the FDA?
Amcath Disposable Cytology Brush (K923200) received a 510(k) decision of Substantially Equivalent on December 7, 1992, 160 days after the submission was received.
What is the product code of K923200?
The FDA product code is FDX – Endoscopic Cytology Brush, a Class II (moderate risk) device regulated under 21 CFR 876.1500.