510(k) K013501

IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B by Gynetics Medical Products NV — Product Code MQF

K013501 is an FDA 510(k) premarket notification submitted by Gynetics Medical Products NV for the device "IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B". The FDA issued a decision of Substantially Equivalent on November 30, 2001. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Gynetics Medical Products NV has at least 3 other 510(k) clearances on record.