510(k) K253525— Urocross Expander System (Model Numbers ES2018 and ES3025)

Substantially Equivalent

Prodeon Medical, Inc.

Clearance details

Applicant: Prodeon Medical, Inc.
Product code: Code QKA
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-13
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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