PuraStat
2 catalogue numbers from 621-043, listed by 3-D Matrix Europe SAS, France, under Hemostatic Device For Endoscopic Gastrointestinal Use. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Endoclot Plus Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | 3-D Matrix Europe SAS, France |
|---|---|
| FDA product code | QAU |
| Device type | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4456 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2026-02-01 |
| Record revised | 2026-04-13 (version 2) |
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 |
| Distribution end date | 2026-04-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 621-043 | In distribution | |
| 621-035 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexpowder | Nextbiomedical Co., Ltd. | 3 |
| Hemospray | Cook Incorporated | 2 |
| PuraStat (3mL) | 3-D Matrix, Ltd. | 1 |
| EndoClot | Endoclot Plus Co., Ltd. | 1 |
| PuraStat (1mL) | 3-D Matrix, Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253924 | 2026-01-07 |
| K242250 | 2024-10-22 |
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.