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510(k) K211032

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr by Urogen Pharma, Ltd. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2021
Date Received
April 7, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Urogen Pharma, Ltd.

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  • K180345 — Uroject12 Syringe Lever (October 17, 2018)

Other clearances for product code KOD

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  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)
  • K171662 — Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-En (February 1, 2018)