510(k) K254076

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit by C.R. Bard, Inc. — Product Code FCM

K254076 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit". The FDA issued a decision of Substantially Equivalent (kit) on May 29, 2026. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.