Injection Needle
Micro-Tech Injection Needle delivers material into tissue through an endoscope. A stainless-steel needle connects to plastic tubing and a Luer-lock hub that accepts a standard syringe.…
Micro-Tech Injection Needle delivers material into tissue through an endoscope. A stainless-steel needle connects to plastic tubing and a Luer-lock hub that accepts a standard syringe.
Injected fluid passes through the needle lumen to the target tissue. The device supports local gastrointestinal injections, including submucosal dye marking.
Listed Item
POM inner tuber,Needle Length 4mm,with metal cap 25G*4*2.3*180,Shroat stucture
Needle and Access Options
The range includes 19, 22 and 25 gauge needles, needle lengths of 4, 5 or 6 mm, and working lengths of 1,800, 2,000 or 2,300 mm. It requires an endoscope channel of at least 2.8 mm. Each needle is single-use and supplied in an ethylene-oxide-sterilized sealed pouch.
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | FBK |
| Device type | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K150434 |
| Record published | 2016-03-10 |
| Record revised | 2025-12-08 (version 7) |
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 | Case of 10, box of 10 |
| Sizes | Length 180 to 230 cm; needle gauge 19 to 25 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IN12-254231802 | Length 180 cm | In distribution |
| IN12-226232302 | Length 230 cm | In distribution |
| IN12-195232302 | Length 230 cm | In distribution |
| IN12-226231802 | Length 180 cm | In distribution |
| IN12-224232002 | Length 200 cm | In distribution |
| IN12-194232002 | In distribution | |
| IN12-256231802 | Length 180 cm | In distribution |
| IN12-225232002 | Length 200 cm | In distribution |
| IN12-196232302 | Length 230 cm | In distribution |
| IN12-223231802 | Length 180 cm | In distribution |
| IN12-194231802 | Length 180 cm | In distribution |
| IN12-223232302 | Length 230 cm | In distribution |
| IN12-196231802 | Length 180 cm | In distribution |
| IN12-255232302 | Length 230 cm | In distribution |
| IN12-224231802 | Length 180 cm | In distribution |
| IN12-195231802 | Length 180 cm | In distribution |
| IN12-255231802 | Length 180 cm | In distribution |
| IN12-254232302 | Length 230 cm | In distribution |
| IN12-256232302 | Length 230 cm | In distribution |
| IN12-253231802 | Length 180 cm | In distribution |
| IN12-195232002 | Length 200 cm | In distribution |
| IN12-226232002 | Length 200 cm | In distribution |
| IN12-254232002 | Length 200 cm | In distribution |
| IN12-224232302 | Length 230 cm | In distribution |
| IN12-253232002 | Length 200 cm | In distribution |
| IN12-253232302 | Length 230 cm | In distribution |
| IN12-196232002 | Length 200 cm | In distribution |
| IN12-223232002 | Length 200 cm | In distribution |
| IN12-256232002 | Length 200 cm | In distribution |
| IN12-255232002 | Length 200 cm | In distribution |
| IN12-194232302 | Length 230 cm | In distribution |
| IN12-225231802 | Length 180 cm | In distribution |
| IN12-225232302 | Length 230 cm | 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 |
| 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 |
| Alton | Alton Shanghai Medical Instruments Co Ltd | 12 |
Showing 12 of 58. All products under Endoscopic Injection Needle, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150434 | 2015-06-02 |
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.