510(k) Report

Devices descending from K210211

4 later devices reach PuraStat-OM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213552PuraStat-RM3-D Matrix, Inc.20223—
+2K261504PuraStat-RM3-D Matrix, Inc.20260—
+2K242634PuraStat3-D Matrix Europe SAS20252—
+3K253923PuraStat3-D Matrix Europe SAS20261—