510(k) K251273

Asurys Fluid Management System by Boston Scientific Corporation — Product Code HIG

K251273 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Asurys Fluid Management System". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.