PuraStat-RM
FDA 510(k) clearance K261504 · decided 2026-08-03
Clearance details
- K-number
- K261504
- Device name
- PuraStat-RM
- Applicant
- 3-D Matrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-05-06
- Decision date
- 2026-08-03
- Days to decision
- 89 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
+ Add to Predicate Builder ◉ Watch 3-D Matrix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PuraStat (K253923) | 3-D Matrix Europe SAS | 2026-01-07 |
| 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.