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FDA 510(k)

Teleflex Rusch SoftSimplastic Foley Catheters

K-Number: K212077 · 2023-07-27

ApplicantTeleflexmedical, Inc.
Decision Date2023-07-27
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Teleflex Rusch SoftSimplastic Foley Catheters is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2023-07-27 under approval number K212077. 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 Teleflex Rusch SoftSimplastic Foley Catheters?

Teleflex Rusch SoftSimplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K212077.

When was Teleflex Rusch SoftSimplastic Foley Catheters approved by the FDA?

Teleflex Rusch SoftSimplastic Foley Catheters received FDA 510(k) clearance on 2023-07-27, under approval number K212077.

What company makes Teleflex Rusch SoftSimplastic Foley Catheters?

Teleflex Rusch SoftSimplastic Foley Catheters is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Teleflex Rusch SoftSimplastic Foley Catheters?

The FDA product code for Teleflex Rusch SoftSimplastic Foley Catheters is EZL.

Related Clinical Trials

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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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