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FDA 510(k)

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

K-Number: K211032 · 2021-11-19

ApplicantUrogen Pharma, Ltd.
Decision Date2021-11-19
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is a medical device manufactured by Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2021-11-19 under approval number K211032. 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 Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Urogen Pharma, Ltd.. The 510(k) number is K211032.

When was Urinary Catheter 12 Fr, Urinary Catheter 16 Fr approved by the FDA?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr received FDA 510(k) clearance on 2021-11-19, under approval number K211032.

What company makes Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is manufactured by Urogen Pharma, Ltd..

What is the FDA product code for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

The FDA product code for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is KOD.

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Other Devices by Urogen Pharma, Ltd.

K180354UroGen Ureteral Catheter K180345Uroject12 Syringe Lever K190987Uroject12 Syringe Lever K203321Cystoject Syringe Lever

Related Devices (Code: KOD)

K161344GentleCath Glide Intermittent CatheterConvatec Limited K160877United Urologics Closed System CatheterRobling Medical, Inc. K172924GentleCath Intermittent Urinary CatheterConvatec Limited K180354UroGen Ureteral CatheterUrogen Pharma, Ltd. K181144Angled Tip Ureteral CatheterCook Incorporated K180530Imager II Urology Torque CatheterBoston Scientific Corporation

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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