EndoClot SIS
EndoClot Submucosal Injection System
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 | Endoclot Plus Co., Ltd., China |
|---|---|
| FDA product code | PLL |
| Device type | Submucosal Injection Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K191254 |
| Record published | 2021-11-16 |
| 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelf box of 5, shipping carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIS-30-01 | In distribution | |
| SIS-15-01 | 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 |
| 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 |
|---|---|
| K191254 | 2020-01-30 |
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.