Clear-Jet Injection Catheter
Clear-Jet Injection Catheter delivers solutions into tissue through an endoscope's working channel. Uses include endoscopic injection for esophageal and gastric varices and submucosal dye…
Clear-Jet Injection Catheter delivers solutions into tissue through an endoscope’s working channel. Uses include endoscopic injection for esophageal and gastric varices and submucosal dye marking in the gastrointestinal tract.
The device connects a stainless steel needle to an inner tube and a slider that accepts a standard syringe. Head versions add a stainless steel distal injector head; non-head versions omit that component.
Listed Item
23G-4mm/ 0.08T/ 2,300mm/ Non-head
Dimensions and Supply
Needle options include 21 and 23 gauge with lengths of 4 or 6 mm. Working lengths are 1,800 and 2,300 mm. Each catheter is supplied sterile for a single patient and must not be reused or resterilized.
Who Else Makes It
Concentrated in Zhejiang (10), Jiangsu (8), Shanghai (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 23. All 23 manufacturers in China registered for Endoscopic Injection Needle, Gastroenterology-Urology
Record
| Listed by | Finemedix, South Korea |
|---|---|
| FDA product code | FBK |
| Device type | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K181690 |
| Record published | 2019-04-12 |
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, serial number |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM-EI0002(I2)(2300)(0.1T) | In distribution | |
| FM-EI0002(2300)(0.05T) | In distribution | |
| FM-EI0002(1800)(0.05T) | In distribution | |
| FM-EI0004(2300)(0.05T) | In distribution | |
| FM-EI0004(2300)(0.1T) | In distribution | |
| FM-EI0002(2300)(0.1T) | In distribution | |
| FM-EI0002(I2)(2300)(0.08T) | In distribution | |
| FM-EI0002(I2)(2300)(0.05T) | In distribution | |
| FM-EI0002(1800)(0.1T) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sclerotherapy needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 248 |
| Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 150 |
| Single Use Injector | Olympus Medical Systems Corp. | 91 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Hangzhou AGS MedTech Co., Ltd. | 90 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 90 |
| Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 62 |
| Disposable Injector NM | Olympus Medical Systems Corp. | 46 |
| Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 33 |
| Cook | Cook Incorporated | 25 |
| Hobbs Posi-Stop Injection Needle | Hobbs Medical, Inc. | 18 |
| Injectra, Sclero Tip | Medi-Globe Gmbh | 14 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 12 |
Showing 12 of 58. All products under Endoscopic Injection Needle, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181690 | 2018-12-21 |
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.