Home / 510(k) Clearances / K171662

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2018
Date Received
June 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
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