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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 the device name listed in this FDA 510(k) record. The listed applicant is Biosensors International Pte, Ltd.. It received FDA 510(k) clearance on 2019-11-06 under 510(k) 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. The listed applicant is Biosensors International Pte, Ltd.. The 510(k) number is K182463.

When did Silicone Foley Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Silicone Foley Catheter?

The FDA 510(k) record lists Biosensors International Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Foley Catheter?

The FDA product code for Silicone Foley Catheter is EZL.

Related Clinical Trials

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.

NCT05931887Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary RetentionCOMPLETEDNCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITING

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

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

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