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)

InnoCare Specialty Foley Catheter

K-Number: K241424 · 2024-09-18

ApplicantInnocare Urologics, LLC
Decision Date2024-09-18
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

InnoCare Specialty Foley Catheter is a medical device manufactured by Innocare Urologics, LLC. It received FDA 510(k) clearance on 2024-09-18 under approval number K241424. 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 InnoCare Specialty Foley Catheter?

InnoCare Specialty Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-09-18. It is manufactured by Innocare Urologics, LLC. The 510(k) number is K241424.

When was InnoCare Specialty Foley Catheter approved by the FDA?

InnoCare Specialty Foley Catheter received FDA 510(k) clearance on 2024-09-18, under approval number K241424.

What company makes InnoCare Specialty Foley Catheter?

InnoCare Specialty Foley Catheter is manufactured by Innocare Urologics, LLC.

What is the FDA product code for InnoCare Specialty Foley Catheter?

The FDA product code for InnoCare Specialty 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

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.

↑