Single Use Cytology Brush
The Single Use Cytology Brush collects cells from the stomach or duodenum through an endoscope. A brush head moves within an assembly containing an outer sheath, catheter, steel wire and…
The Single Use Cytology Brush collects cells from the stomach or duodenum through an endoscope. A brush head moves within an assembly containing an outer sheath, catheter, steel wire and sliding handle.
Moving the finger ring back and forth advances or retracts the brush head. This mechanical movement brings the sampling brush to the target site for cellular collection.
Size and Supply Options
The family has 21 specifications varying in brush diameter, brush length, sheath outside diameter and effective length. Each device is ethylene-oxide sterilized, supplied in sterile packaging and intended for a single use. The stated packaged shelf life is three years.
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
Record
| Listed by | Zhejiang Chuangxiang Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | FDX |
| Device type | Endoscopic Cytology Brush |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K220063 |
| Record published | 2023-05-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD-L-CB-1210-1006 | In distribution | |
| MD-L-CB-3716-5010 | In distribution | |
| MD-L-CB-2012-3010 | In distribution | |
| MD-U-CB-2012-4008 | In distribution | |
| MD-L-CB-2012-5010 | In distribution | |
| MD-L-CB-2820-3010 | In distribution | |
| MD-L-CB-2012-1210 | In distribution | |
| MD-L-CB-3723-5010 | In distribution | |
| MD-L-CB-1212-2006 | In distribution | |
| MD-L-CB-1207-1006 | In distribution | |
| MD-U-CB-2016-4008 | In distribution | |
| MD-L-CB-2023-2010 | In distribution | |
| MD-L-CB-2823-3010 | In distribution | |
| MD-U-CB-3723-6008 | In distribution | |
| MD-L-CB-2816-3010 | In distribution | |
| MD-L-CB-2020-2010 | In distribution | |
| MD-L-CB-3720-5010 | In distribution | |
| MD-L-CB-2007-2010 | In distribution | |
| MD-U-CB-2820-6008 | In distribution | |
| MD-L-CB-2012-2010 | In distribution | |
| MD-L-CB-2016-2010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conmed | ConMed Corporation | 12 |
| Halyard | Avanos Medical, Inc. | 8 |
| Cytology Brush | Avanos Medical, Inc. | 8 |
| Cook | Cook Incorporated | 7 |
| Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | 7 |
| Hobbs Medical Cytology Brush | Hobbs Medical, Inc. | 6 |
| Infinity | Us Endoscopy | 6 |
| Disposable Gastrointestinal Cytology Brush | TeleMed Systems | 6 |
| EndoTBrush Cytology Brush | Endo-Therapeutics, Inc. | 5 |
| CytoMax II | Cook Incorporated | 5 |
| Foreign Body Retrieval Basket | Avanos Medical, Inc. | 5 |
| superDimension | Covidien LP | 4 |
Showing 12 of 27. All products under Endoscopic Cytology Brush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220063 | 2022-07-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.