510(k) K261342— Urocross Expander System (UES-2018-C1)

Substantially Equivalent

Prodeon Medical, Inc.

Clearance details

Applicant: Prodeon Medical, Inc.
Product code: Code QKA
Advisory panel: Gastroenterology, Urology
Date received: 2026-04-23
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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