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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 the device name listed in this FDA 510(k) record. The listed applicant is Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) 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. The listed applicant is Urogen Pharma, Ltd.. The 510(k) number is K180354.

When did UroGen Ureteral Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for UroGen Ureteral Catheter?

The FDA 510(k) record lists Urogen Pharma, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UroGen Ureteral Catheter?

The FDA product code for UroGen Ureteral Catheter is KOD.

Other records listing Urogen Pharma, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrK203321Cystoject Syringe LeverK190987Uroject12 Syringe LeverK180345Uroject12 Syringe Lever

Related Devices (Code: KOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K181144Angled Tip Ureteral CatheterCook Incorporated

Official Source

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

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