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FDA 510(k)

Rusch Intermittent Urethral Catheters

K-Number: K222279 · 2022-08-29

ApplicantTeleflex Medical
Decision Date2022-08-29
Product CodeEZC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch Intermittent Urethral Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K222279. The device is classified under product code EZC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rusch Intermittent Urethral Catheters?

Rusch Intermittent Urethral Catheters is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Teleflex Medical. The 510(k) number is K222279.

When did Rusch Intermittent Urethral Catheters receive FDA 510(k) clearance?

Rusch Intermittent Urethral Catheters received FDA 510(k) clearance on 2022-08-29, under 510(k) number K222279.

Who is the listed applicant for Rusch Intermittent Urethral Catheters?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rusch Intermittent Urethral Catheters?

The FDA product code for Rusch Intermittent Urethral Catheters is EZC.

Related Clinical Trials

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NCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITING

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Related Devices (Code: EZC)

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.

K173596Rusch Intermittent Urethral CathetersTeleflex Medical

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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