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FDA 510(k)

Yikang Latex Foley Catheter

K-Number: K173340 · 2018-07-13

ApplicantJiangxi Yikang Medical Instrument Group Co., Ltd.
Decision Date2018-07-13
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Yikang Latex Foley Catheter is a medical device manufactured by Jiangxi Yikang Medical Instrument Group Co., Ltd.. It received FDA 510(k) clearance on 2018-07-13 under approval number K173340. 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 Yikang Latex Foley Catheter?

Yikang Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Jiangxi Yikang Medical Instrument Group Co., Ltd.. The 510(k) number is K173340.

When was Yikang Latex Foley Catheter approved by the FDA?

Yikang Latex Foley Catheter received FDA 510(k) clearance on 2018-07-13, under approval number K173340.

What company makes Yikang Latex Foley Catheter?

Yikang Latex Foley Catheter is manufactured by Jiangxi Yikang Medical Instrument Group Co., Ltd..

What is the FDA product code for Yikang Latex Foley Catheter?

The FDA product code for Yikang Latex 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

Other Devices by Jiangxi Yikang Medical Instrument Group Co., Ltd.

K190213Yikang Endotracheal Tube

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.

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