EndoClot Submucosal Injection System EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage…
EndoClot Submucosal Injection System EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1).
Record
Regulatory record for EndoClot | 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 | 2021-06-23 |
| Record revised | 2024-06-19 (version 3) |
Specifications
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 |
| Storage | Storage environment temperature -3 to 33 °C |
| Packaging | Pack of 5, shelf box of 5 |
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.