510(k) K833330
- Device
- MUTO BRUSH
- Applicant
- MICROVASIVE
- 510(k) number
- K833330
- Product code
- FDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-14
- Date received
- 1983-09-27
- Regulation
- 876.1500
- Classification name
- Endoscopic Cytology Brush
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014769442
- 2183744
- 1721686
- 1828132
- 3009888344
- 3011270181
- 2528981
- 3004083736
- 3008797804
- 3004837686
- 9611594
- 1223925
- 1320894
- 2246552
- 1222168
- 3003790304
- 3005099803
- 3030446844
- 1056129
- 1220592
- 2183873
- 3007305485
- 3004111573
- 3005987240
- 1000121056
- 1825146
- 1061927
- 1037905
- 9614641
- 3011050570
- 8010047
- 3021023752
- 1000393132
- 1047843
- 1643817
- 3018094310
- 1820334
- 3013460719
- 1528319
- 3013440400
- 9710641
- 3004962788
- 9681260
- 3013023255
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FDX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | 2025-12-18 |
| K220063 | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-07-28 |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | 2019-11-14 |
| K191485 | Deflectable Brush Biopsy Set | Cook Incorporated | 2019-06-26 |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated | 2019-05-01 |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2019-02-08 |
| K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | 2018-03-05 |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2017-12-29 |
| K171607 | Bronchi and Gastrointestinal Cytology Brush | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-07-31 |
| K151889 | Infinity ERCP Sampling Device | United States Endoscopy Group, Inc. | 2015-07-30 |
| K103437 | US ENDOSCOPY CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | 2010-12-23 |
| K052279 | COOK IRELAND ECHOBRUSH | Cook Ireland, Ltd. | 2005-10-11 |
| K040324 | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | Wilson-Cook Medical, Inc. | 2004-05-20 |
| K021998 | HORIZONS CYTOLOGY BRUSH | Horizons Intl. Corp. | 2002-07-12 |
| K965037 | CELL RECOVERY SYSTEM | Medical Device Technologies, Inc. | 1997-01-08 |
Legacy Summary#
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FDA Review#
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