InjecSURE ®
The InjecSURE system is intended to deliver injectable materials into urethral tissues of the lower urinary tract during cystoscopic procedures. The single-use system includes a 20-gauge,…
The InjecSURE system is intended to deliver injectable materials into urethral tissues of the lower urinary tract during cystoscopic procedures.
The single-use system includes a 20-gauge, five-inch needle with pencil-point or spinal tip options and a disposable sheath.
Listed Item
Endoscopic Injection System
Accessory Design
The sheath attaches to a cystoscope and provides a guided pathway for the needle. It is compatible with 2.7 mm cystoscopes of various lengths. The system components are specified for single-patient use.
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 | Carbon Medical Technologies, Inc., United States |
|---|---|
| FDA product code | FBK |
| Device type | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K253598 |
| Record published | 2026-04-09 |
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 | Carton |
| Sizes | Length 110 to 127 mm; needle gauge 20 G; length 5 in; outer diameter 2.7 mm; angle 0 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 890-313S | Needle Gauge 20 G | In distribution |
| 890-305PS | Needle Gauge 20 G | In distribution |
| 890-310P | Needle Gauge 20 G | In distribution |
| 890-313P | Needle Gauge 20 G | In distribution |
| 890-305SS | Needle Gauge 20 G | In distribution |
| 890-310S | Needle Gauge 20 G | 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 |
|---|---|
| K253598 | 2026-03-31 |
| K172227 | 2017-08-23 |
| K133148 | 2014-05-13 |
| K042615 | 2004-11-05 |
| K030451 | 2003-04-30 |
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.