PEW — Implantable Transprostatic Tissue Retractor System Class II
Classification Details
- Product Code
- PEW
- Device Class
- Class II
- Regulation Number
- 876.5530
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232558 | neotract | UroLift 2 ATC Advanced Tissue Control System | September 22, 2023 |
| K201837 | neotract | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant | July 31, 2020 |
| K200441 | neotract | UroLift Advanced Tissue Control (ATC) System | June 5, 2020 |
| K193269 | neotract | UroLift System (UL400) | December 20, 2019 |
| K190377 | neotract | UroLift System UL400 | March 21, 2019 |
| K173087 | neotract | UroLift System (UL400 and UL500) | December 28, 2017 |
| K172359 | neotract | UroLift System (UL500) | August 18, 2017 |
| K162345 | neotract | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | September 21, 2016 |
| K153584 | neotract | NeoTract UroLift System UL500 | March 15, 2016 |
| K133281 | neotract | NEOTRACT UROLIFT SYSTEM | December 20, 2013 |
| DEN130023 | neotract | UROLIFT SYSTEM | September 13, 2013 |