DEN190020 is an FDA 510(k) submission for the iTind System. This device is classified as a Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia (Class II - Special Controls, product code QKA).
Submitted by Medi-Tate , Ltd. (Or-Akiva, IL). The FDA issued a Not Cleared (DENG) decision on February 25, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5510. 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..
| 510(k) Number | DEN190020 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 02, 2019 |
| Decision Date | February 25, 2020 |
| Days to Decision | 329 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QKA - Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5510 |
| Definition | 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. |