RX Cytology Brush
Wireguided Cytology Brush
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FDX |
| Device type | Endoscopic Cytology Brush |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
|---|---|---|
| M00545000 | 2.7 mm Diameter | 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 |
| 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 |
Showing 12 of 27. All products under Endoscopic Cytology Brush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K930348 | 1993-09-03 |
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.