510(k) Report

Devices descending from K222481

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242250PuraStat3-D Matrix Europe SAS20242—
+2K261503PuraStat GI3-D Matrix, Inc.20260—
+2K253924PuraStat3-D Matrix Europe SAS20261—