Rusch SoftSimplastic Foley Catheters
K-Number: K252537 · 2026-01-20
ApplicantTeleflex Medical Sdn. Bhd.
Decision Date2026-01-20
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Rusch SoftSimplastic Foley Catheters is a medical device manufactured by Teleflex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2026-01-20 under approval number K252537. 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 Rusch SoftSimplastic Foley Catheters?
Rusch SoftSimplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2026-01-20. It is manufactured by Teleflex Medical Sdn. Bhd.. The 510(k) number is K252537.
When was Rusch SoftSimplastic Foley Catheters approved by the FDA?
Rusch SoftSimplastic Foley Catheters received FDA 510(k) clearance on 2026-01-20, under approval number K252537.
What company makes Rusch SoftSimplastic Foley Catheters?
Rusch SoftSimplastic Foley Catheters is manufactured by Teleflex Medical Sdn. Bhd..
What is the FDA product code for Rusch SoftSimplastic Foley Catheters?
The FDA product code for Rusch SoftSimplastic Foley Catheters is EZL.
Related Clinical Trials
Other Devices by Teleflex Medical Sdn. Bhd.
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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.