Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Catheter, Urological

UroGen Pharma Ltd

The following data is part of a premarket notification filed by Urogen Pharma Ltd with the FDA for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr.

Pre-market Notification Details

Device IDK211032
510k NumberK211032
Device Name:Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
ClassificationCatheter, Urological
Applicant UroGen Pharma Ltd 9 Ha'Ta'asiya Street Ra'anana,  IL 4365405
ContactJames G. Otinger
CorrespondentJames G. Otinger
UroGen Pharma Inc 400 Alexander Park Drive Princeton,  NJ  08540
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-07
Decision Date2021-11-19

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