Blue Eye
2 catalogue numbers from TS-910, listed by THE Standard Co., Ltd., South Korea, under Submucosal Injection Agent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
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 | THE Standard Co., Ltd., South Korea |
|---|---|
| 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) | K241591 |
| Record published | 2024-08-16 |
| Record revised | 2024-09-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton box of 12, paper box of 5, canister of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS-910 | In distribution | |
| TS-905 | 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 |
| 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 |
|---|---|
| K241591 | 2024-07-03 |
| K220434 | 2022-08-12 |
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.