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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 the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-08 under 510(k) 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. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K202134.

When did Well Lead All Silicone Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Well Lead Medical Co., Ltd. as applicant

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Related Devices (Code: EZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

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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