510(k) Report

Devices descending from K210098

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222481PuraStat3-D Matrix, Inc.20233—
+2K242250PuraStat3-D Matrix Europe SAS20242—
+3K261503PuraStat GI3-D Matrix, Inc.20260—
+3K253924PuraStat3-D Matrix Europe SAS20261—