PuraStat-RM
FDA 510(k) clearance K213552 · decided 2022-04-01
Clearance details
- K-number
- K213552
- Device name
- PuraStat-RM
- Applicant
- 3-D Matrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-08
- Decision date
- 2022-04-01
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- PHN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Newton, MA, US
- 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 (K253923) | 3-D Matrix Europe SAS | 2026-01-07 |
| PuraStat (K242634) | 3-D Matrix Europe SAS | 2025-01-15 |
| PROCTIGARD (K140558) | Access Pharmaceuticals, Inc. | 2014-07-16 |
Recalls involving this device
No recalls on record reference this clearance.