510(k) K242541

GEM ZIPCLIP by Synovis Micro Companies Alliance A Subsidiary of Baxter Int — Product Code FZP

K242541 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance A Subsidiary of Baxter Int for the device "GEM ZIPCLIP". The FDA issued a decision of Substantially Equivalent on January 15, 2025. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300.