Home / 510(k) Clearances / K101824

510(k) K101824

AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER by Amsino International, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2010
Date Received
July 1, 2010
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 Amsino International, Inc.

  • K220230 — AMSure Enteral Feeding Pump (November 10, 2022)
  • K220267 — AMSafe NeuFlo Needleless Connector (October 7, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)
  • K200051 — PUGGLE Enteral Feeding Pump and Feeding Set (September 25, 2020)
  • K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe (July 12, 2019)
  • K181445 — AMSure Hydrophilic Intermittent Catheter (October 1, 2018)
  • K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (September 7, 2018)
  • K173665 — AMSafe Sure-Lok Needle-Free Connector (September 5, 2018)
  • K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (September 4, 2018)
  • K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip (March 30, 2018)

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)
  • K231101 — Flume Catheter (June 29, 2023)
  • K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accu (January 13, 2023)