Urocross Expander System (Model Numbers ES2018 and ES3025)
K-Number: K253525 · 2026-03-12
Device Summary
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. The listed applicant is Prodeon Medical, Inc.. The 510(k) number is K253525.
When did Urocross Expander System (Model Numbers ES2018 and ES3025) receive FDA 510(k) clearance?
Urocross Expander System (Model Numbers ES2018 and ES3025) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K253525.
Who is the listed applicant for Urocross Expander System (Model Numbers ES2018 and ES3025)?
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 (Model Numbers ES2018 and ES3025)?
The FDA product code for Urocross Expander System (Model Numbers ES2018 and ES3025) 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.
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.
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.