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510(k) K261342

Device
Urocross Expander System (UES-2018-C1)
Applicant
Prodeon Medical, Inc.
510(k) number
K261342
Product code
QKA
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-22
Date received
2026-04-23
Regulation
876.5510
Classification name
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Elaine Aplaon
Address
2200 Zanker Rd., Unit F San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QKA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253525Urocross Expander System (Model Numbers ES2018 and ES3025)Prodeon Medical, Inc.2026-03-12
K210138iTind SystemMedi-Tate , Ltd.2021-06-25
DEN190020iTind SystemMedi-Tate , Ltd.2020-02-25