Single Use Injector
The Olympus Single Use Injector NM-400/NM-401 is an endoscopic injection needle for vascular or submucosal injection in the digestive tract. It is intended for use with Olympus endoscopes.…
The Olympus Single Use Injector NM-400/NM-401 is an endoscopic injection needle for vascular or submucosal injection in the digestive tract. It is intended for use with Olympus endoscopes. A handle slider extends and retracts the needle, while an injection port delivers fluid to the target tissue.
The range includes 21 to 25 gauge needles with working lengths from 1,650 to 2,700 mm. The assembly has handle, needle and sheath sections. Materials include stainless steel, polypropylene and perfluoroalkoxy; the outer tube is polypropylene and the inner tube is perfluoroalkoxy.
Needle Configurations and Supply
Models include lancet-bevel and flat-bevel needle shapes, with some insertion diameters as small as 1.9 mm for smaller endoscope channels. Devices are supplied sterile after ethylene oxide sterilization and intended for single use. The stated shelf life is three years.
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FBK |
| Device type | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K252247 |
| Record published | 2016-09-21 |
| Record revised | 2022-08-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 8 |
| Distribution end date | 2022-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NM-400U-0623 | In distribution | |
| NM-401L-0625 | In distribution | |
| NM-400U-0525 | In distribution | |
| NM-400U-0425 | In distribution | |
| NM-400L-0423 | In distribution | |
| NM-401L-0523 | In distribution | |
| NM-400U-0525 | In distribution | |
| NM-400U-0323 | In distribution | |
| NM-401L-0525 | In distribution | |
| NM-400L-0625 | In distribution | |
| NM-401L-0425 | In distribution | |
| NM-400L-0423 | In distribution | |
| NM-400U-0523 | In distribution | |
| NM-401L-0423 | In distribution | |
| NM-400U-0625 | In distribution | |
| NM-400L-0425 | In distribution | |
| NM-400L-0423 | In distribution | |
| NM-400U-0323 | In distribution | |
| NM-400L-0523 | In distribution | |
| NM-400U-0425 | In distribution | |
| NM-401L-0625 | In distribution | |
| NM-400U-0425 | In distribution | |
| NM-400L-0421 | In distribution | |
| NM-400L-0425 | In distribution | |
| NM-400L-0425 | In distribution | |
| NM-400L-0421 | In distribution | |
| NM-400L-0525 | In distribution | |
| NM-401L-0525 | In distribution | |
| NM-400U-0423 | In distribution | |
| NM-401L-0425 | In distribution | |
| NM-401L-0623 | In distribution | |
| NM-401L-0523 | In distribution | |
| NM-401L-0623 | In distribution | |
| NM-400Y-0423 | In distribution | |
| NM-400L-0621 | In distribution | |
| NM-400L-0623 | In distribution | |
| NM-401L-0625 | In distribution | |
| NM-400L-0625 | In distribution | |
| NM-400U-0423 | In distribution | |
| NM-401L-0623 | In distribution | |
| NM-401L-0423 | In distribution | |
| NM-400U-0525 | In distribution | |
| NM-400L-0623 | In distribution | |
| NM-400L-0621 | In distribution | |
| NM-401L-0425 | In distribution | |
| NM-400L-0523 | In distribution | |
| NM-401L-0523 | In distribution | |
| NM-400U-0523 | In distribution | |
| NM-400L-0525 | In distribution | |
| NM-401L-0525 | In distribution | |
| NM-400U-0425 | In distribution | |
| NM-400Y-0423 | In distribution | |
| NM-400L-0525 | In distribution | |
| NM-400L-0423 | In distribution | |
| NM-400U-0423 | In distribution | |
| NM-401L-0423 | In distribution | |
| NM-400L-0625 | In distribution | |
| NM-400U-0625 | In distribution | |
| NM-400L-0421 | In distribution | |
| NM-400U-0623 | In distribution | |
| NM-400U-0523 | In distribution | |
| NM-401L-0423 | In distribution | |
| NM-400L-0523 | In distribution | |
| NM-400L-0621 | In distribution | |
| NM-400U-0323 | In distribution | |
| NM-400L-0623 | In distribution | |
| NM-400U-0623 | In distribution | |
| NM-400U-0625 | In distribution | |
| NM-400Y-0423 | In distribution | |
| NM-400U-0623 | Withdrawn | |
| NM-401L-0523 | Withdrawn | |
| NM-400L-0423 | Withdrawn | |
| NM-401L-0623 | Withdrawn | |
| NM-400Y-0423 | Withdrawn | |
| NM-400L-0525 | Withdrawn | |
| NM-400L-0425 | Withdrawn | |
| NM-400U-0523 | Withdrawn | |
| NM-400L-0625 | Withdrawn | |
| NM-401L-0525 | Withdrawn | |
| NM-400U-0425 | Withdrawn | |
| NM-400U-0323 | Withdrawn | |
| NM-400L-0421 | Withdrawn | |
| NM-400L-0621 | Withdrawn | |
| NM-400U-0625 | Withdrawn | |
| NM-400L-0623 | Withdrawn | |
| NM-401L-0625 | Withdrawn | |
| NM-400U-0423 | Withdrawn | |
| NM-401L-0423 | Withdrawn | |
| NM-400L-0523 | Withdrawn | |
| NM-400U-0525 | Withdrawn | |
| NM-401L-0425 | Withdrawn |
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 |
| 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 |
|---|---|
| K252247 | 2025-10-16 |
| K192498 | 2020-04-28 |
| K153625 | 2016-02-12 |
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.