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FDA 510(k)

Urocross Expander System (Model Numbers ES2018 and ES3025)

K-Number: K253525 · 2026-03-12

ApplicantProdeon Medical, Inc.
Decision Date2026-03-12
Product CodeQKA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Urocross Expander System (Model Numbers ES2018 and ES3025) is a medical device manufactured by Prodeon Medical, Inc.. It received FDA 510(k) clearance on 2026-03-12 under approval number K253525. The device is classified under product code QKA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Urocross Expander System (Model Numbers ES2018 and ES3025)?

Urocross Expander System (Model Numbers ES2018 and ES3025) is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Prodeon Medical, Inc.. The 510(k) number is K253525.

When was Urocross Expander System (Model Numbers ES2018 and ES3025) approved by the FDA?

Urocross Expander System (Model Numbers ES2018 and ES3025) received FDA 510(k) clearance on 2026-03-12, under approval number K253525.

What company makes Urocross Expander System (Model Numbers ES2018 and ES3025)?

Urocross Expander System (Model Numbers ES2018 and ES3025) is manufactured by Prodeon Medical, Inc..

What is the FDA product code for Urocross Expander System (Model Numbers ES2018 and ES3025)?

The FDA product code for Urocross Expander System (Model Numbers ES2018 and ES3025) is QKA.

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Other Devices by Prodeon Medical, Inc.

K252572Prodeon Urethral Sheath System

Related Devices (Code: QKA)

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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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