Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Silicone Foley Catheter

K-Number: K182463 · 2019-11-06

ApplicantBiosensors International Pte, Ltd.
Decision Date2019-11-06
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Silicone Foley Catheter is a medical device manufactured by Biosensors International Pte, Ltd.. It received FDA 510(k) clearance on 2019-11-06 under approval number K182463. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silicone Foley Catheter?

Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Biosensors International Pte, Ltd.. The 510(k) number is K182463.

When was Silicone Foley Catheter approved by the FDA?

Silicone Foley Catheter received FDA 510(k) clearance on 2019-11-06, under approval number K182463.

What company makes Silicone Foley Catheter?

Silicone Foley Catheter is manufactured by Biosensors International Pte, Ltd..

What is the FDA product code for Silicone Foley Catheter?

The FDA product code for Silicone Foley Catheter is EZL.

Related Clinical Trials

NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT02932319 Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy COMPLETED NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING NCT07530328 Clinical Evaluation of Copesilcup COMPLETED

Related Devices (Code: EZL)

K153655Accuryn Monitoring SystemPotrero Medical, Inc. K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc. K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. K181616PSM 3-Way Silicone Foley CatheterPathway, LLC K180781Bard Vertus Foley CatheterC.R. Bard, Inc. K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑