DEN130023 is an FDA 510(k) submission for the UROLIFT SYSTEM. This device is classified as a Implantable Transprostatic Tissue Retractor System (Class II - Special Controls, product code PEW).
Submitted by Neotract, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on September 13, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5530. The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above..
| 510(k) Number | DEN130023 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 07, 2013 |
| Decision Date | September 13, 2013 |
| Days to Decision | 190 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | PEW - Implantable Transprostatic Tissue Retractor System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5530 |
| Definition | The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above. |