K253923 is an FDA 510(k) clearance for the PuraStat. This device is classified as a Protective Coating, Mucoadhesive Application, For The Rectal Mucosa.
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 Gastroenterology & Urology FDA review panel. Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa..
| 510(k) Number | K253923 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 | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PHN - Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Device Class | - |
| Definition | Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa. |