PuraStat
FDA 510(k) clearance K253923 · decided 2026-01-07
Clearance details
- K-number
- K253923
- Device name
- PuraStat
- Applicant
- 3-D Matrix Europe SAS
- Decision
- Substantially Equivalent
- Date received
- 2025-12-08
- Decision date
- 2026-01-07
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PHN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Caluire Et Cuire, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PuraStat-RM (K261504) | 3-D Matrix, Inc. | 2026-08-03 |
| PuraStat (K242634) | 3-D Matrix Europe SAS | 2025-01-15 |
| PuraStat-RM (K213552) | 3-D Matrix, Inc. | 2022-04-01 |
| PROCTIGARD (K140558) | Access Pharmaceuticals, Inc. | 2014-07-16 |
Recalls involving this device
No recalls on record reference this clearance.