510(k) K242795

Getinge Assured MI Steam Migrating Integrator by Steritec Products Mfg. (A Getinge Group Company) — Product Code JOJ

K242795 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg. (A Getinge Group Company) for the device "Getinge Assured MI Steam Migrating Integrator". The FDA issued a decision of Substantially Equivalent on October 15, 2024. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.