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510(k) K211032

Device
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
Applicant
UroGen Pharma Ltd
510(k) number
K211032
Product code
KOD  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-19
Date received
2021-04-07
Regulation
876.5130
Classification name
Catheter, Urological
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
James G. Otinger
Address
9 Ha'Ta'Asiya St. Ra'Anana IL 4365405 4365405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251864Rubber Utility CatheterC.R. Bard, Inc.2026-02-23
K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.2022-12-16
K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.2022-10-13
K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.2019-05-24
K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.2018-10-30
K181144Angled Tip Ureteral CatheterCook Incorporated2018-06-28
K180530Imager II Urology Torque CatheterBoston Scientific Corporation2018-04-10
K171810Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterCook Incorporated2018-03-07
K171600Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated2018-02-16
K171662Open-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 CatheterCook Incorporated2018-02-01
K172924GentleCath Intermittent Urinary CatheterConvatec Limited2017-11-21
K161344GentleCath Glide Intermittent CatheterConvatec Limited2016-09-20
K160877United Urologics Closed System CatheterRobling Medical, Inc.2016-05-20
K140953GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETERConvatec, Ltd.2014-08-01
K110491BACKSTOP CATHETERPluromed, Inc.2011-03-16

Legacy Summary#

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FDA Review#

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