510(k) K172321

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters by Cook Incorporated — Product Code MQF

K172321 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters". The FDA issued a decision of Substantially Equivalent on December 21, 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.