510(k) K180258

SpeediCath Standard by Coloplast — Product Code GBM

K180258 is an FDA 510(k) premarket notification submitted by Coloplast for the device "SpeediCath Standard". The FDA issued a decision of Substantially Equivalent on October 25, 2018. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Coloplast has at least 10 other 510(k) clearances on record.