Sclerotherapy Needle
The Sclerotherapy Needle is an endoscopic injection instrument for delivering fluid into gastrointestinal mucosa. Its flexible sheath passes through an endoscope channel to reach the…
The Sclerotherapy Needle is an endoscopic injection instrument for delivering fluid into gastrointestinal mucosa. Its flexible sheath passes through an endoscope channel to reach the selected site in the digestive tract.
The instrument combines a Luer connector and handle with an infusion tube, sheath and needle. Advancing the connector exposes the needle beyond the sheath so it can enter the target tissue for injection. The range includes versions with and without a fixed button.
Listed Item
without fixed button
Materials and Formats
The sheath is PTFE and the needle is stainless steel. Working lengths range from 1,200 to 2,300 mm, with a minimum endoscope working channel of 2.8 mm. Each device is supplied in an ethylene-oxide-sterilized pouch for single use.
23manufacturers in China registered for this device type
248catalogue numbers in this listing
1510(k) clearance
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 | Zhejiang Chuangxiang Medical Technology 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, Repacker / relabeller, Manufacturer |
| 510(k) | K212668 |
| Record published | 2022-12-21 |
| Record revised | 2022-08-18 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD-B-SY-1812-2504 | In distribution | |
| MD-A-SY-2418-2304 | In distribution | |
| MD-B-SY-2420-1904 | In distribution | |
| MD-B-SY-2418-2106 | In distribution | |
| MD-A-SY-1818-2506 | In distribution | |
| MD-B-SY-1818-2104 | In distribution | |
| MD-A-SY-2418-2312 | In distribution | |
| MD-A-SY-2412-2108 | In distribution | |
| MD-B-SY-2420-1906 | In distribution | |
| MD-A-SY-2423-1906 | In distribution | |
| MD-A-SY-2418-2310 | In distribution | |
| MD-B-SY-2423-1906 | In distribution | |
| MD-A-SY-1812-2506 | In distribution | |
| MD-A-SY-2418-2504 | In distribution | |
| MD-B-SY-2418-2508 | In distribution | |
| MD-B-SY-2418-2306 | In distribution | |
| MD-A-SY-2423-2106 | In distribution | |
| MD-A-SY-2420-2506 | In distribution | |
| MD-A-SY-1818-2104 | In distribution | |
| MD-A-SY-2418-2304 | In distribution | |
| MD-A-SY-2418-2308 | In distribution | |
| MD-A-SY-2418-2306 | In distribution | |
| MD-A-SY-2412-2308 | In distribution | |
| MD-A-SY-1818-2304 | In distribution | |
| MD-A-SY-1818-2306 | In distribution | |
| MD-A-SY-2412-2306 | In distribution | |
| MD-B-SY-2412-2306 | In distribution | |
| MD-A-SY-2423-2104 | In distribution | |
| MD-B-SY-2418-2112 | In distribution | |
| MD-A-SY-2423-2306 | In distribution | |
| MD-B-SY-2418-1906 | In distribution | |
| MD-A-SY-2418-2510 | In distribution | |
| MD-B-SY-2412-2510 | In distribution | |
| MD-A-SY-2420-2306 | In distribution | |
| MD-A-SY-2412-1906 | In distribution | |
| MD-B-SY-2423-1904 | In distribution | |
| MD-B-SY-2418-2512 | In distribution | |
| MD-A-SY-1812-2304 | In distribution | |
| MD-B-SY-2418-2110 | In distribution | |
| MD-B-SY-2423-2304 | In distribution | |
| MD-A-SY-2418-1906 | In distribution | |
| MD-A-SY-2420-2106 | In distribution | |
| MD-B-SY-2423-2504 | In distribution | |
| MD-B-SY-1818-2106 | In distribution | |
| MD-B-SY-2418-2308 | In distribution | |
| MD-A-SY-2412-2510 | In distribution | |
| MD-B-SY-2412-2512 | In distribution | |
| MD-A-SY-2420-2304 | In distribution | |
| MD-B-SY-2418-2310 | In distribution | |
| MD-B-SY-2412-2104 | In distribution | |
| MD-A-SY-2418-2110 | In distribution | |
| MD-B-SY-2418-1904 | In distribution | |
| MD-A-SY-1818-2304 | In distribution | |
| MD-A-SY-2420-1906 | In distribution | |
| MD-B-SY-2418-2104 | In distribution | |
| MD-A-SY-2412-2306 | In distribution | |
| MD-B-SY-2412-2312 | In distribution | |
| MD-B-SY-2412-2310 | In distribution | |
| MD-B-SY-2412-2112 | In distribution | |
| MD-A-SY-2412-2504 | In distribution | |
| MD-B-SY-2420-2104 | In distribution | |
| MD-A-SY-1812-2106 | In distribution | |
| MD-B-SY-2418-2508 | In distribution | |
| MD-B-SY-1818-2504 | In distribution | |
| MD-A-SY-2412-2506 | In distribution | |
| MD-A-SY-1812-2306 | In distribution | |
| MD-A-SY-2420-2104 | In distribution | |
| MD-A-SY-2423-2306 | In distribution | |
| MD-B-SY-2412-2308 | In distribution | |
| MD-A-SY-2418-2112 | In distribution | |
| MD-A-SY-2418-2504 | In distribution | |
| MD-A-SY-2423-2106 | In distribution | |
| MD-B-SY-2412-2506 | In distribution | |
| MD-B-SY-1812-2106 | In distribution | |
| MD-B-SY-2412-2304 | In distribution | |
| MD-A-SY-2412-2506 | In distribution | |
| MD-A-SY-2412-2510 | In distribution | |
| MD-A-SY-2418-2308 | In distribution | |
| MD-A-SY-1812-2306 | In distribution | |
| MD-A-SY-2423-2506 | In distribution | |
| MD-A-SY-2412-2304 | In distribution | |
| MD-A-SY-2412-2304 | In distribution | |
| MD-A-SY-1812-2504 | In distribution | |
| MD-A-SY-2418-2112 | In distribution | |
| MD-A-SY-1818-2106 | In distribution | |
| MD-B-SY-1818-2306 | In distribution | |
| MD-A-SY-2412-2110 | In distribution | |
| MD-A-SY-2412-2508 | In distribution | |
| MD-A-SY-2412-2312 | In distribution | |
| MD-B-SY-2418-2110 | In distribution | |
| MD-B-SY-2423-1904 | In distribution | |
| MD-A-SY-2423-2304 | In distribution | |
| MD-A-SY-2418-2312 | In distribution | |
| MD-B-SY-2412-2312 | In distribution | |
| MD-A-SY-2412-2512 | In distribution | |
| MD-B-SY-2418-2310 | In distribution | |
| MD-A-SY-2418-2110 | In distribution | |
| MD-A-SY-2412-2504 | In distribution | |
| MD-A-SY-2412-2308 | In distribution | |
| MD-B-SY-2420-2504 | In distribution | |
| MD-A-SY-2420-2504 | In distribution | |
| MD-A-SY-2412-2508 | In distribution | |
| MD-B-SY-2412-2110 | In distribution | |
| MD-A-SY-2423-2504 | In distribution | |
| MD-B-SY-2418-2106 | In distribution | |
| MD-B-SY-2412-2308 | In distribution | |
| MD-B-SY-1812-2304 | In distribution | |
| MD-A-SY-2418-2104 | In distribution | |
| MD-B-SY-2420-2306 | In distribution | |
| MD-A-SY-2420-1906 | In distribution | |
| MD-A-SY-2420-2504 | In distribution | |
| MD-A-SY-2418-2510 | In distribution | |
| MD-B-SY-2412-2306 | In distribution | |
| MD-A-SY-2412-1904 | In distribution | |
| MD-A-SY-1818-2104 | In distribution | |
| MD-B-SY-2412-2504 | In distribution | |
| MD-B-SY-2412-2106 | In distribution | |
| MD-B-SY-2412-2310 | In distribution | |
| MD-B-SY-2418-2504 | In distribution | |
| MD-B-SY-2420-2304 | In distribution | |
| MD-A-SY-2412-2310 | In distribution | |
| MD-B-SY-2418-2306 | In distribution | |
| MD-A-SY-2420-2506 | In distribution | |
| MD-B-SY-2423-2106 | In distribution | |
| MD-B-SY-2418-2108 | In distribution | |
| MD-A-SY-2412-1904 | In distribution | |
| MD-B-SY-2423-2104 | In distribution | |
| MD-B-SY-2418-1904 | In distribution | |
| MD-A-SY-2418-2508 | In distribution | |
| MD-B-SY-2418-1906 | In distribution | |
| MD-B-SY-2418-2304 | In distribution | |
| MD-B-SY-1818-2506 | In distribution | |
| MD-B-SY-2418-2506 | In distribution | |
| MD-B-SY-2418-2104 | In distribution | |
| MD-B-SY-1818-2506 | In distribution | |
| MD-A-SY-1812-2504 | In distribution | |
| MD-B-SY-2423-2506 | In distribution | |
| MD-B-SY-2412-1906 | In distribution | |
| MD-B-SY-1818-2304 | In distribution | |
| MD-B-SY-2423-2306 | In distribution | |
| MD-B-SY-2423-2106 | In distribution | |
| MD-B-SY-2418-2308 | In distribution | |
| MD-A-SY-1812-2304 | In distribution | |
| MD-A-SY-2418-2506 | In distribution | |
| MD-A-SY-2420-1904 | In distribution | |
| MD-B-SY-2412-2110 | In distribution | |
| MD-B-SY-2420-2104 | In distribution | |
| MD-B-SY-1818-2106 | In distribution | |
| MD-B-SY-2423-2304 | In distribution | |
| MD-A-SY-1818-2106 | In distribution | |
| MD-B-SY-1818-2306 | In distribution | |
| MD-A-SY-2412-2112 | In distribution | |
| MD-B-SY-2412-2106 | In distribution | |
| MD-A-SY-2420-1904 | In distribution | |
| MD-B-SY-2412-2506 | In distribution | |
| MD-B-SY-1812-2506 | In distribution | |
| MD-A-SY-2420-2104 | In distribution | |
| MD-A-SY-2412-2104 | In distribution | |
| MD-B-SY-2418-2312 | In distribution | |
| MD-B-SY-2412-2108 | In distribution | |
| MD-B-SY-2418-2312 | In distribution | |
| MD-B-SY-2412-2506 | In distribution | |
| MD-A-SY-2418-2310 | In distribution | |
| MD-B-SY-1818-2104 | In distribution | |
| MD-A-SY-2412-2108 | In distribution | |
| MD-A-SY-2412-2104 | In distribution | |
| MD-A-SY-2412-2106 | In distribution | |
| MD-A-SY-2418-2508 | In distribution | |
| MD-A-SY-2418-2512 | In distribution | |
| MD-B-SY-2420-2306 | In distribution | |
| MD-A-SY-2420-2106 | In distribution | |
| MD-B-SY-2412-2512 | In distribution | |
| MD-B-SY-2423-2104 | In distribution | |
| MD-B-SY-1812-2506 | In distribution | |
| MD-A-SY-2418-1906 | In distribution | |
| MD-A-SY-2423-1904 | In distribution | |
| MD-A-SY-1818-2306 | In distribution | |
| MD-A-SY-1812-2106 | In distribution | |
| MD-A-SY-2418-2106 | In distribution | |
| MD-A-SY-2418-2512 | In distribution | |
| MD-A-SY-2418-2506 | In distribution | |
| MD-A-SY-2412-2312 | In distribution | |
| MD-A-SY-2418-2306 | In distribution | |
| MD-B-SY-2412-2108 | In distribution | |
| MD-B-SY-1812-2304 | In distribution | |
| MD-A-SY-2423-2506 | In distribution | |
| MD-A-SY-2412-1906 | In distribution | |
| MD-B-SY-2412-2510 | In distribution | |
| MD-A-SY-2423-1906 | In distribution | |
| MD-B-SY-1812-2106 | In distribution | |
| MD-B-SY-1812-2104 | In distribution | |
| MD-B-SY-2418-2108 | In distribution | |
| MD-A-SY-2423-2104 | In distribution | |
| MD-B-SY-2423-2504 | In distribution | |
| MD-B-SY-1818-2304 | In distribution | |
| MD-B-SY-2420-2506 | In distribution | |
| MD-B-SY-2420-1906 | In distribution | |
| MD-A-SY-1812-2104 | In distribution | |
| MD-B-SY-1812-2306 | In distribution | |
| MD-A-SY-1818-2504 | In distribution | |
| MD-B-SY-2420-2106 | In distribution | |
| MD-A-SY-2423-2304 | In distribution | |
| MD-B-SY-2412-2508 | In distribution | |
| MD-B-SY-1812-2306 | In distribution | |
| MD-B-SY-2418-2512 | In distribution | |
| MD-A-SY-1812-2506 | In distribution | |
| MD-A-SY-1812-2104 | In distribution | |
| MD-B-SY-2412-2112 | In distribution | |
| MD-A-SY-2418-2108 | In distribution | |
| MD-B-SY-2420-2504 | In distribution | |
| MD-A-SY-2420-2306 | In distribution | |
| MD-B-SY-2423-2506 | In distribution | |
| MD-A-SY-1818-2506 | In distribution | |
| MD-A-SY-2412-2512 | In distribution | |
| MD-B-SY-2418-2510 | In distribution | |
| MD-B-SY-2418-2504 | In distribution | |
| MD-A-SY-2412-2110 | In distribution | |
| MD-A-SY-2418-2106 | In distribution | |
| MD-B-SY-2418-2506 | In distribution | |
| MD-A-SY-2418-1904 | In distribution | |
| MD-B-SY-1812-2104 | In distribution | |
| MD-B-SY-2418-2304 | In distribution | |
| MD-B-SY-1818-2504 | In distribution | |
| MD-A-SY-2412-2310 | In distribution | |
| MD-A-SY-2418-2104 | In distribution | |
| MD-B-SY-2412-2508 | In distribution | |
| MD-B-SY-2412-2304 | In distribution | |
| MD-A-SY-2423-2504 | In distribution | |
| MD-A-SY-2412-2112 | In distribution | |
| MD-A-SY-2420-2304 | In distribution | |
| MD-B-SY-2412-2104 | In distribution | |
| MD-A-SY-2418-1904 | In distribution | |
| MD-A-SY-2423-1904 | In distribution | |
| MD-B-SY-2420-2106 | In distribution | |
| MD-B-SY-2423-1906 | In distribution | |
| MD-B-SY-2418-2510 | In distribution | |
| MD-B-SY-2420-1904 | In distribution | |
| MD-A-SY-2418-2108 | In distribution | |
| MD-B-SY-2412-1904 | In distribution | |
| MD-B-SY-2423-2306 | In distribution | |
| MD-B-SY-2420-2304 | In distribution | |
| MD-B-SY-2412-2504 | In distribution | |
| MD-B-SY-2412-1906 | In distribution | |
| MD-A-SY-1818-2504 | In distribution | |
| MD-B-SY-2418-2112 | In distribution | |
| MD-B-SY-1812-2504 | In distribution | |
| MD-B-SY-2420-2506 | In distribution | |
| MD-A-SY-2412-2106 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K212668 | 2022-02-23 |
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.