Cytology Brush
Flexible endoscopic cytology brush
5manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Endo-Therapeutics, Inc., United States |
|---|---|
| FDA product code | FDX |
| Device type | Endoscopic Cytology Brush |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K800966 |
| Record published | 2016-09-20 |
| Record revised | 2023-12-18 (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 |
| Storage | Special storage condition: Keep Dry |
| Packaging | Box of 10 |
| Sizes | Outer diameter 1.7 to 2.4 mm; length 110 to 220 cm |
| Distribution end date | 2019-11-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB-1311 | Brush Diameter 3.0 mm | Withdrawn |
| CB-1315 | Brush Diameter 3.0 mm | Withdrawn |
| CB-1622 | Min Channel 2.8 mm | Withdrawn |
| CB-1615 | Brush Diameter 3.0 mm | Withdrawn |
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
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.