510(k) K142545

SonoFlow Sonohysterography and Sonohysterosalpingography Device by Crossbay Medical, Inc. — Product Code LKF

K142545 is an FDA 510(k) premarket notification submitted by Crossbay Medical, Inc. for the device "SonoFlow Sonohysterography and Sonohysterosalpingography Device". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Crossbay Medical, Inc. has at least 5 other 510(k) clearances on record.