510(k) Report

Devices descending from K212200

3 later devices reach STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+1K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd.20230—
+1K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—