510(k) Report

Devices descending from K103210

15 later devices reach Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp.201510—
+1K123162U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollU&U Medical Technology Co, Ltd.20140—
+1K112087Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products20122—
+2K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation20189—
+2K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products201411
+3K241123Perpak™ Sterilization Tyvek PouchKm Corp.20240—
+3K221379Steriking LT-Blueline Pouches with TyvekWipak OY20231—
+3K221377SteriKing LT-Blueline Pouches with TyvekWipak OY20221—
+3K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd.20213—
+3K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…Advanced Sterilization Products20170—
+4K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+4K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+4K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+4K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd.20230—
+4K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—