PuraStat
K-Number: K253923 · 2026-01-07
Applicant3-D Matrix Europe SAS
Decision Date2026-01-07
Product CodePHN
DecisionSubstantially Equivalent
Device Summary
PuraStat is a medical device manufactured by 3-D Matrix Europe SAS. It received FDA 510(k) clearance on 2026-01-07 under approval number K253923. The device is classified under product code PHN. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PuraStat?
PuraStat is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by 3-D Matrix Europe SAS. The 510(k) number is K253923.
When was PuraStat approved by the FDA?
PuraStat received FDA 510(k) clearance on 2026-01-07, under approval number K253923.
What company makes PuraStat?
PuraStat is manufactured by 3-D Matrix Europe SAS.
What is the FDA product code for PuraStat?
The FDA product code for PuraStat is PHN.
Other Devices by 3-D Matrix Europe SAS
Related Devices (Code: PHN)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.