510(k) K943851

ALL SILICONE INTERMITTENT CATHETER by Rochester Medical Corp. — Product Code GBM

K943851 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "ALL SILICONE INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.