510(k) Report

Devices descending from K212198

3 later devices reach Tyvek (R) Roll with CI for STERLINKTM Sterilizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+1K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd.20230—
+1K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—