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510(k) K253525

Urocross Expander System (Model Numbers ES2018 and ES3025) by Prodeon Medical, Inc. — Product Code QKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
November 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device Class
Class II
Regulation Number
876.5510
Review Panel
GU
Submission Type

A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

Other clearances by Prodeon Medical, Inc.

  • K252572 — Prodeon Urethral Sheath System (October 7, 2025)

Other clearances for product code QKA

  • K210138 — iTind System (June 25, 2021)
  • DEN190020 — iTind System (February 25, 2020)