BlueBoost(TM) Submucosal Injectable Solution
Product is sky-blue viscous liquid, the content is 10ml. Initial packaging is the syringe.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | PLL |
| Device type | Submucosal Injection Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K200071 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-08 (version 6) |
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 |
| Packaging | Box of 12, case of 9 |
| Sizes | Total volume 5 to 10 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SML10 | Total Volume 10 ml | In distribution |
| SML05 | Total Volume 5 ml | 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 |
| 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 |
| Eleview 5mL | Cosmo Technologies Ltd. | 1 |
| Ascendo submucosal lifting agent | Us Endoscopy | 1 |
| Ascendo | Us Endoscopy | 1 |
| LiftUp Kit | Ovesco Endoscopy AG | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200071 | 2020-11-03 |
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.