K162345 is an FDA 510(k) clearance for the UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge. 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 Cleared decision on September 21, 2016, 30 days after receiving the submission on August 22, 2016.
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 | K162345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2016 |
| Decision Date | September 21, 2016 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |