K253924 is an FDA 510(k) clearance for the PuraStat. This device is classified as a Hemostatic Device For Endoscopic Gastrointestinal Use (Class II - Special Controls, product code QAU).
Submitted by 3-D Matrix Europe SAS (Caluire Et Cuire, FR). The FDA issued a Cleared decision on January 7, 2026, 30 days after receiving the submission on December 8, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4456. Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means..
| 510(k) Number | K253924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2025 |
| Decision Date | January 07, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QAU - Hemostatic Device For Endoscopic Gastrointestinal Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4456 |
| Definition | Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means. |