M.R. Assoc. Cytology Brushes
FDA 510(k) K800966 · Mr Associates, Inc.
510(k) numberK800966
Submission
- Device name
- M.R. Assoc. Cytology Brushes
- Applicant
- Mr Associates, Inc.
Mchenry, IL, US - Received
- April 23, 1980
- Decision date
- May 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K800976 | M.R. Assoc. W Type Grasping ForcepsOCZ · Traditional | 05/08/1980SE |
| K800975 | M.R. Assoc. True-Feel HandleKNS · Traditional | 05/08/1980SE |
| K800974 | M.R. Assoc. Power CordKNS · Traditional | 05/08/1980SE |
| K800973 | M.R. Assoc. Hot Biopsy ForcepsKNS · Traditional | 05/08/1980SE |
| K800972 | M.R. Assoc. Tripod Grasping ForcepsOCZ · Traditional | 05/08/1980SE |
| K800971 | M.R. Assoc. Magnetic ExtractorFCC · Traditional | 05/08/1980SE |
| K800970 | M.R. Assoc. Basket RetrieversOCZ · Traditional | 05/08/1980SE |
| K800969 | M.R. Assoc. CannulasOCZ · Traditional | 05/08/1980SE |
| K800968 | M.R. Assoc. Rat Tooth Grasp ForcepsOCZ · Traditional | 05/08/1980SE |
| K800967 | M.R. Assoc. Alligator Graspong ForcepsOCZ · Traditional | 05/08/1980SE |
Questions and answers
When was M.R. Assoc. Cytology Brushes cleared by the FDA?
M.R. Assoc. Cytology Brushes (K800966) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 15 days after the submission was received.
What is the product code of K800966?
The FDA product code is FDX – Endoscopic Cytology Brush, a Class II (moderate risk) device regulated under 21 CFR 876.1500.