510(k) K254111

Irrigation/Urology Sets by B.Braun Medical, Inc. — Product Code LJH

K254111 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Irrigation/Urology Sets". The FDA issued a decision of Substantially Equivalent on September 10, 2026. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.