510(k) K904158

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY by Welcon, Inc. — Product Code FCM

K904158 is an FDA 510(k) premarket notification submitted by Welcon, Inc. for the device "ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 29, 1990. 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. Welcon, Inc. has at least 7 other 510(k) clearances on record.