Data / Medical devices / United States / Urotronic Inc
Urotronic Inc: FDA-registered device maker in Plymouth, MN, United States, 1 510(k) clearance and 2 PMA approvals
Urotronic Inc is registered with the FDA (registration 3015228875) in Plymouth, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance and 2 PMA approvals under its listings, the newest dated June 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015228875
- Address
- 2495 Xenium Lane North, Plymouth, MN, United States, 55441
- Owner or operator
- Urotronic Inc (10063084)
- Roles
- Manufacturer
- First device listed
- March 16, 2020
- Registered through
- 2026
- Brand names listed
- Optilume BPH Catheter System, Optilume Basic Urological Balloon Dilation Catheter, Optilume® Urethral Drug Coated Balloon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Balloon, Urethral, Drug-Coated | QRH | 3 | Manufacturer | accessdata.fda.gov |
| Dilator, Urethral | KOE | 2 | Manufacturer | accessdata.fda.gov |
| Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia | QXB | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 2, 2020 | K191061 | Optilume Basic Urological Balloon Dilation Catheter | KOE | Substantially Equivalent | Urotronic, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 30, 2023 | P220029 | Optilume BPH Catheter System | QXB | 4 | December 15, 2025 | accessdata.fda.gov |
| December 3, 2021 | P210020 | Optilume Urethral Drug Coated Balloon | QRH | 9 | June 23, 2025 | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.