Home / 510(k) Clearances / K231101

510(k) K231101

Flume Catheter by Flume Catheter Company, Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2023
Date Received
April 18, 2023
Clearance Type
Special
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 Flume Catheter Company, Ltd.

  • K212151 — FLUME catheter (November 3, 2021)

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)
  • 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)
  • 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)