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FDA 510(k)

UroGen Ureteral Catheter

K-Number: K180354 · 2018-10-30

ApplicantUrogen Pharma, Ltd.
Decision Date2018-10-30
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UroGen Ureteral Catheter is a medical device manufactured by Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2018-10-30 under approval number K180354. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UroGen Ureteral Catheter?

UroGen Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2018-10-30. It is manufactured by Urogen Pharma, Ltd.. The 510(k) number is K180354.

When was UroGen Ureteral Catheter approved by the FDA?

UroGen Ureteral Catheter received FDA 510(k) clearance on 2018-10-30, under approval number K180354.

What company makes UroGen Ureteral Catheter?

UroGen Ureteral Catheter is manufactured by Urogen Pharma, Ltd..

What is the FDA product code for UroGen Ureteral Catheter?

The FDA product code for UroGen Ureteral Catheter is KOD.

Related Clinical Trials

NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

Other Devices by Urogen Pharma, Ltd.

K180345Uroject12 Syringe Lever K190987Uroject12 Syringe Lever K203321Cystoject Syringe Lever K211032Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Related Devices (Code: KOD)

K161344GentleCath Glide Intermittent CatheterConvatec Limited K160877United Urologics Closed System CatheterRobling Medical, Inc. K172924GentleCath Intermittent Urinary CatheterConvatec Limited K181144Angled Tip Ureteral CatheterCook Incorporated K180530Imager II Urology Torque CatheterBoston Scientific Corporation K171810Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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