K200441 is an FDA 510(k) clearance for the UroLift Advanced Tissue Control (ATC) 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 Cleared decision on June 5, 2020, 102 days after receiving the submission on February 24, 2020.
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 | K200441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2020 |
| Decision Date | June 05, 2020 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| 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. |