EverLift
EverLift is an agent used in gastrointestinal endoscopic procedures to lift the submucosa beneath polyps, adenomas, early-stage cancers or other gastrointestinal lesions before excision.…
EverLift is an agent used in gastrointestinal endoscopic procedures to lift the submucosa beneath polyps, adenomas, early-stage cancers or other gastrointestinal lesions before excision.
The filing describes injection into the submucosal layer through a standard endoscopic injection needle inserted in the endoscope’s working channel. The injected composition forms a cushion in place.
Listed Item
Submucosal Lifting Agent – 10mL Single Unit
Use Before Excision
The described lift separates the gastrointestinal mucosa from the submucosal layer before removal with a snare or another appropriate endoscopic device. The filing identifies EverLift as a single-use agent.
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 | GI Supply, United States |
|---|---|
| FDA product code | PLL |
| Device type | Submucosal Injection Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191923 |
| Record published | 2021-02-18 |
| 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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GIS-55 | In distribution | |
| GIS-59 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orise™ Gel | Boston Scientific Corporation | 4 |
| Eleview | Cosmo Technologies Ltd. | 3 |
| 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 |
| 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 |
|---|---|
| K202376 | 2020-09-30 |
| K191923 | 2020-06-20 |
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.