510(k) K180552

Modified Novy Cornual Cannulation Set by Cook Incorporated — Product Code MOV

K180552 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Modified Novy Cornual Cannulation Set". The FDA issued a decision of Substantially Equivalent on July 12, 2018. The device falls under product code MOV (Catheters, Salpingography), a Class II device regulated under 21 CFR 884.4530. Cook Incorporated has at least 10 other 510(k) clearances on record.