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510(k) K232469

Rüsch Latex Gold Foley Catheter by Teleflexmedical, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
August 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Teleflexmedical, Inc.

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  • K192324 — Sheridan Spiral-Flex Endotracheal Tubes (December 6, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 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 EZL

  • K252537 — Rusch SoftSimplastic Foley Catheters (January 20, 2026)
  • K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter) (June 16, 2025)
  • K241424 — InnoCare Specialty Foley Catheter (September 18, 2024)
  • K240057 — TraumaGuard Intra-abdominal Pressure Sensing System (April 17, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K233013 — 2-Way 100% Silicone Cleartract Catheter (January 23, 2024)
  • K212077 — Teleflex Rusch SoftSimplastic Foley Catheters (July 27, 2023)
  • K231101 — Flume Catheter (June 29, 2023)
  • K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accu (January 13, 2023)
  • K222118 — 2-Way 100% Silicone Cleartract Catheter (December 1, 2022)