Howell
Howell Biliary Introducer Brush
5manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | FDX |
| Device type | Endoscopic Cytology Brush |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2020-10-09 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2020-09-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G22919 | Withdrawn |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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191485 | 2019-06-26 |
| K182231 | 2019-05-01 |
| K770913 | 1977-06-01 |
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.