510(k) K170298

Liberator Beacon Tip Locking Stylet by Cook Incorporated — Product Code DRB

K170298 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Liberator Beacon Tip Locking Stylet". The FDA issued a decision of Substantially Equivalent on October 18, 2017. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Cook Incorporated has at least 10 other 510(k) clearances on record.