PEW — Implantable Transprostatic Tissue Retractor System Class II
FDA product code PEW covers "Implantable Transprostatic Tissue Retractor System", a Class II medical device regulated under 21 CFR 876.5530. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 11 recent 510(k) clearances have been granted under this product code.
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 |