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510(k) K024010

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER by The Kendall Company Div. of Tyco Healthcare Group — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2003
Date Received
December 4, 2002
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 The Kendall Company Div. of Tyco Healthcare Group

  • K831081 — EZEE FILTER/SEPARATOR (May 16, 1983)
  • K831082 — CONNECTING TUBING (May 9, 1983)
  • K831079 — LIQUIPETTE (April 28, 1983)

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  • K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter) (June 16, 2025)
  • K241424 — InnoCare Specialty Foley Catheter (September 18, 2024)
  • K232469 — Rüsch Latex Gold Foley Catheter (August 1, 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)