510(k) K090960

VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, by Hollister, Inc. — Product Code GBM

K090960 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,". The FDA issued a decision of Substantially Equivalent on August 20, 2009. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hollister, Inc. has at least 10 other 510(k) clearances on record.