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FDA 510(k)

Urocross Expander System (UES-2018-C1)

K-Number: K261342 · 2026-06-22

ApplicantProdeon Medical, Inc.
Decision Date2026-06-22
Product CodeQKA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Urocross Expander System (UES-2018-C1) is the device name listed in this FDA 510(k) record. The listed applicant is Prodeon Medical, Inc.. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K261342. 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 (UES-2018-C1)?

Urocross Expander System (UES-2018-C1) is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Prodeon Medical, Inc.. The 510(k) number is K261342.

When did Urocross Expander System (UES-2018-C1) receive FDA 510(k) clearance?

Urocross Expander System (UES-2018-C1) received FDA 510(k) clearance on 2026-06-22, under 510(k) number K261342.

Who is the listed applicant for Urocross Expander System (UES-2018-C1)?

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

What is the FDA product code for Urocross Expander System (UES-2018-C1)?

The FDA product code for Urocross Expander System (UES-2018-C1) is QKA.

Other records listing Prodeon Medical, Inc. as applicant

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.

K253525Urocross Expander System (Model Numbers ES2018 and ES3025)K252572Prodeon Urethral Sheath System

Related Devices (Code: QKA)

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.

K253525Urocross Expander System (Model Numbers ES2018 and ES3025)Prodeon Medical, Inc.K210138iTind SystemMedi-Tate , Ltd.

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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