K191061 is an FDA 510(k) clearance for the Optilume Basic Urological Balloon Dilation Catheter. This device is classified as a Dilator, Urethral (Class II - Special Controls, product code KOE).
Submitted by Urotronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 2, 2020, 255 days after receiving the submission on April 22, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K191061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2019 |
| Decision Date | January 02, 2020 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOE - Dilator, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5520 |