510(k) K163598

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator by Advanced Sterilization Products — Product Code KCT

K163598 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator". The FDA issued a decision of Substantially Equivalent on July 31, 2017. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.