510(k) Report

Devices descending from K112087

2 later devices reach Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products201411
+2K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…Advanced Sterilization Products20170—