510(k) K180824

VaPro 2 Intermittent Catheter by Hollister Incorporated — Product Code GBM

K180824 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "VaPro 2 Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on June 22, 2018. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hollister Incorporated has at least 10 other 510(k) clearances on record.