510(k) K163318

Soules Intrauterine Insemination Catheter by Cook Incorporated — Product Code MQF

K163318 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Soules Intrauterine Insemination Catheter". The FDA issued a decision of Substantially Equivalent on July 14, 2017. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Cook Incorporated has at least 10 other 510(k) clearances on record.