Cytology Brush
Cytology Brush from Micro-Tech collects cells from the bronchi and upper or lower gastrointestinal tract. A brush head moves within an outer sheath under control of a proximal handle and…
Cytology Brush from Micro-Tech collects cells from the bronchi and upper or lower gastrointestinal tract. A brush head moves within an outer sheath under control of a proximal handle and finger ring.
Moving the finger ring back and forth advances or retracts the brush to collect cells at the target site. Configurations vary in brush diameter, sheath diameter, working length and finger-ring color.
Listed Item
With sheath, 2 mm brush head, diameter of sheath 1.8 mm, working length 1200 mm
Supply and Size
The listed sheathed version has a 2 mm brush head, 1.8 mm sheath and 1,200 mm working length. Devices are sterilized with ethylene oxide and packaged to maintain sterility for a two-year shelf life.
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | FDX |
| Device type | Endoscopic Cytology Brush |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K172663 |
| Record published | 2021-12-31 |
| Record revised | 2025-12-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20, case of 10 |
| Sizes | Outer diameter 1.8 to 2.3 mm; length 120 to 240 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CYB-20S-12C | Outer Diameter 1.8 mm | In distribution |
| CYB-30S-18C | Outer Diameter 2.3 mm | In distribution |
| CYB-20S-18C | Outer Diameter 2.3 mm | In distribution |
| CYB-30S-24C | Outer Diameter 2.3 mm | In distribution |
| CYB-50S-12C | Outer Diameter 1.8 mm | In distribution |
| CYB-50S-24C | Outer Diameter 2.3 mm | In distribution |
| CYB-30S-12C | Outer Diameter 1.8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 21 |
| Conmed | ConMed Corporation | 12 |
| Halyard | Avanos Medical, Inc. | 8 |
| Cytology Brush | Avanos Medical, Inc. | 8 |
| Cook | Cook Incorporated | 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 |
|---|---|
| K172663 | 2018-03-05 |
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.