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510(k) K181979

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter by Teleflexmedical, Inc. — Product Code KOD

K181979 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on May 24, 2019. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2019
Date Received
July 25, 2018
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 Teleflexmedical, Inc.

  • K232469 — Rüsch Latex Gold Foley Catheter (August 1, 2024)
  • K212077 — Teleflex Rusch SoftSimplastic Foley Catheters (July 27, 2023)
  • K192324 — Sheridan Spiral-Flex Endotracheal Tubes (December 6, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)
  • K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermitt (May 8, 2019)
  • K181852 — Percuvance Percutaneous Surgical System (October 12, 2018)
  • K173280 — Neonatal ConchaSmart Breathing Circuits (August 2, 2018)
  • K172775 — MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (February 12, 2018)
  • K161770 — Rusch Silicone Foley Catheter (May 5, 2017)
  • K162522 — UltraCath Continuous Nerve block Catheter (March 17, 2017)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • 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)

FDA data resources