Chrysalis Intelligence · Sponsors · Urotronic, Inc.

Urotronic, Inc.

Minneapolis, MN, US · 2 510(k) clearances · 15 PMAs

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
2
2020-01-02 → 2025-05-22
Last 12 months
0
Product codes
2
Most recent
2025-05-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EZN Dilator, Catheter, Ureteral Class II Gastroenterology, Urology 1 2025-05-22
KOE Dilator, Urethral Class II Gastroenterology, Urology 1 2020-01-02
Class III

PMA approvals (15)

Total PMA records
15
Originals + supplements
Distinct product codes
2
First decision
2021-12-03
Most recent
2025-12-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-12-15 P220029-S003 Optilume™ BPH Catheter System Normal 180 Day Track No User Fee QXB — —
2025-12-12 P220029-S004 Optilume™ BPH Catheter System 30-Day Notice QXB — —
2025-06-23 P210020-S010 Optilume Urethral Drug Coated Balloon Catheter Normal 180 Day Track QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2024-08-15 P220029-S002 Optilume™ BPH Catheter System Normal 180 Day Track QXB — —
2024-01-13 P210020-S009 Optilume Urethral Drug Coated Balloon catheter 30-Day Notice QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2023-08-25 P220029-S001 Optilume™ BPH Catheter System Normal 180 Day Track No User Fee QXB — —
2023-06-30 P220029 Optilume™ BPH Catheter System Original QXB — —
2023-04-25 P210020-S008 Optilume Urethral Drug Coated Balloon 30-Day Notice QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2022-09-29 P210020-S006 Optilume Urethral Drug Coated Balloon Normal 180 Day Track No User Fee QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2022-06-10 P210020-S005 Optilume Urethral Drug Coated Balloon Normal 180 Day Track No User Fee QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2022-05-17 P210020-S004 Optilume Urethral Drug Coated Balloon Real-Time Process QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2022-02-03 P210020-S003 Optilume Urethral Drug Coated Balloon Normal 180 Day Track No User Fee QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2022-01-27 P210020-S002 Optilume Urethral Drug Coated Balloon Normal 180 Day Track No User Fee QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2022-01-19 P210020-S001 Optilume Urethral Drug Coated Balloon Normal 180 Day Track No User Fee QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
2021-12-03 P210020 Optilume Urethral Drug Coated Balloon Original QRH Catheter, Balloon, Urethral, Drug-Coated Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-05-22 K250910 Optilume® High Pressure Urological Balloon Dilation Catheter EZN Class II Gastroenterology, Urology
2020-01-02 K191061 Optilume Basic Urological Balloon Dilation Catheter KOE Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence