Endoscopic Injection Needle, Gastroenterology-Urology
the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 24, needle extension length is 4 mm, the headend type is tip forming.
23manufacturers in China registered for this device type
90catalogue 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 | Hangzhou AGS MedTech Co., Ltd., China |
|---|---|
| FDA product code | FBK |
| Device type | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K190032 |
| Record published | 2021-12-01 |
| Record revised | 2023-03-27 (version 2) |
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 |
| Packaging | Box of 10, carton of 100, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AG-5311-2420-2106M | model of needle, needle extension length | In distribution |
| AG-5313-2423-2106M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2104M | model of needle, needle extension length | In distribution |
| AG-5313-2416-2206M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2404 | model of needle, needle extension length | In distribution |
| AG-5313-2423-2304M | model of needle, needle extension length | In distribution |
| AG-5313-2420-2304M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2104 | model of needle, needle extension length | In distribution |
| AG-5311-2416-2204 | model of needle, needle extension length | In distribution |
| AG-5313-2420-2204M | model of needle, needle extension length | In distribution |
| AG-5313-2420-2104M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2504M | model of needle, needle extension length | In distribution |
| AG-5313-2423-2404M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2406M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2304M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2106M | model of needle, needle extension length | In distribution |
| AG-5313-2416-2506M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2506M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2104M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2306M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2304 | model of needle, needle extension length | In distribution |
| AG-5313-2420-2506M | model of needle, needle extension length | In distribution |
| AG-5313-2423-2104M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2506M | model of needle, needle extension length | In distribution |
| AG-5313-2423-2206M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2504M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2204M | In distribution | |
| AG-5311-2416-2506 | model of needle, needle extension length | In distribution |
| AG-5311-2423-2406M | model of needle, needle extension length | In distribution |
| AG-5313-2416-2304M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2104 | model of needle, needle extension length | In distribution |
| AG-5313-2420-2406M | model of needle, needle extension length | In distribution |
| AG-5313-2416-2204M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2206M | In distribution | |
| AG-5313-2416-2104M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2406M | model of needle, needle extension length | In distribution |
| AG-5313-2420-2404M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2304 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2204 | model of needle, needle extension length | In distribution |
| AG-5311-2423-2204 | model of needle, needle extension length | In distribution |
| AG-5313-2423-2406M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2106M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2104M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2506 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2306 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2204M | In distribution | |
| AG-5311-2420-2404 | model of needle, needle extension length | In distribution |
| AG-5313-2420-2106M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2106 | model of needle, needle extension length | In distribution |
| AG-5311-2416-2404M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2504 | model of needle, needle extension length | In distribution |
| AG-5311-2416-2206 | model of needle, needle extension length | In distribution |
| AG-5313-2423-2504M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2406 | model of needle, needle extension length | In distribution |
| AG-5313-2416-2106M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2306 | model of needle, needle extension length | In distribution |
| AG-5313-2416-2406M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2306 | model of needle, needle extension length | In distribution |
| AG-5311-2423-2506 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2506M | model of needle, needle extension length | In distribution |
| AG-5313-2420-2504M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2304M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2206 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2206M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2304M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2404 | model of needle, needle extension length | In distribution |
| AG-5311-2423-2404M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2404M | model of needle, needle extension length | In distribution |
| AG-5313-2420-2206M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2306M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2204M | In distribution | |
| AG-5311-2420-2504 | model of needle, needle extension length | In distribution |
| AG-5313-2416-2306M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2106 | model of needle, needle extension length | In distribution |
| AG-5311-2416-2106 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2206 | model of needle, needle extension length | In distribution |
| AG-5313-2420-2306M | model of needle, needle extension length | In distribution |
| AG-5313-2416-2504M | model of needle, needle extension length | In distribution |
| AG-5313-2423-2204M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2104 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2504M | model of needle, needle extension length | In distribution |
| AG-5311-2416-2406 | model of needle, needle extension length | In distribution |
| AG-5313-2423-2506M | model of needle, needle extension length | In distribution |
| AG-5313-2423-2306M | model of needle, needle extension length | In distribution |
| AG-5311-2420-2306M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2304 | model of needle, needle extension length | In distribution |
| AG-5311-2423-2206M | model of needle, needle extension length | In distribution |
| AG-5313-2416-2404M | model of needle, needle extension length | In distribution |
| AG-5311-2423-2504 | model of needle, needle extension length | In distribution |
| AG-5311-2420-2406 | model of needle, needle extension length | 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 |
| 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 |
|---|---|
| K190032 | 2020-02-27 |
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.