510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253525Substantially Equivalent

Urocross Expander System (Model Numbers ES2018 and ES3025)

Prodeon Medical, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253525 is the FDA 510(k) clearance record for Urocross Expander System (Model Numbers ES2018 and ES3025), a class II device, cleared for Prodeon Medical, Inc. on under FDA product code QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia). FDA's definition for product code QKA reads: "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". FDA records list 3 510(k) clearances for Prodeon Medical, Inc., from to . As of , FDA records show no recalls naming K253525.

Clearance record

Decision date
Received
(119 days to decision)
Product code
QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Regulation
21 CFR 876.5510
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Prodeon Medical, Inc. 452 Oakmead Pkwy., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QKA

Trailing 12 months
2 clearances under product code QKA in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260