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FDA 510(k)

Well Lead All Silicone Foley Catheter with Temperature Sensor

K-Number: K202134 · 2021-04-08

ApplicantWell Lead Medical Co., Ltd.
Decision Date2021-04-08
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Well Lead All Silicone Foley Catheter with Temperature Sensor is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-08 under approval number K202134. 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 Well Lead All Silicone Foley Catheter with Temperature Sensor?

Well Lead All Silicone Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2021-04-08. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K202134.

When was Well Lead All Silicone Foley Catheter with Temperature Sensor approved by the FDA?

Well Lead All Silicone Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2021-04-08, under approval number K202134.

What company makes Well Lead All Silicone Foley Catheter with Temperature Sensor?

Well Lead All Silicone Foley Catheter with Temperature Sensor is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor is EZL.

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Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K161110ClearPetra Suction-Evacuation Sheath K151084Well Lead Ureteral Access Sheath K162340Stomach Tube K182739Endotracheal Tube with Evacuation Lumen K203119ClearPetra Suction-Evacuation Sheath

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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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