510(k) Report

Devices descending from K213552

3 later devices reach PuraStat-RM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261504PuraStat-RM3-D Matrix, Inc.20260—
+1K242634PuraStat3-D Matrix Europe SAS20252—
+2K253923PuraStat3-D Matrix Europe SAS20261—