510(k) K171662

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter by Cook Incorporated — Product Code KOD

K171662 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter". The FDA issued a decision of Substantially Equivalent on February 1, 2018. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Cook Incorporated has at least 10 other 510(k) clearances on record.