510(k) K252584

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) by Weyo Surgical Technology , Ltd. — Product Code HIF

K252584 is an FDA 510(k) premarket notification submitted by Weyo Surgical Technology , Ltd. for the device "Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)". The FDA issued a decision of Substantially Equivalent on June 25, 2026. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730.