510(k) K252307

Getinge GSS67N Series Steam Sterilizer by Maquet GmbH (A Getinge Group Company) — Product Code FLE

K252307 is an FDA 510(k) premarket notification submitted by Maquet GmbH (A Getinge Group Company) for the device "Getinge GSS67N Series Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on January 22, 2026. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880.