Eleview 5ml
5 ampoules, 5 mL each. To Facilitate endoscopic resection procedures
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Endoclot Plus Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Cosmo Technologies Ltd., Ireland |
|---|---|
| FDA product code | PLL |
| Device type | Submucosal Injection Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2022-04-01 |
| Record revised | 2024-06-19 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9000025 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orise™ Gel | Boston Scientific Corporation | 4 |
| Eleview | Cosmo Technologies Ltd. | 3 |
| EverLift | GI Supply | 2 |
| BlueBoost(TM) Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | 2 |
| EndoClot | Endoclot Plus Co., Ltd. | 2 |
| Blue Eye | THE Standard Co., Ltd. | 2 |
| EndoClot SIS | Endoclot Plus Co., Ltd. | 2 |
| LiftUp | Ovesco Endoscopy AG | 1 |
| Ascendo submucosal lifting agent | Us Endoscopy | 1 |
| Ascendo | Us Endoscopy | 1 |
| LiftUp Kit | Ovesco Endoscopy AG | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150852 | 2015-09-03 |
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.