PEW
11 FDA 510(k) clearances · Product code
30 daysmedian time to decision
102 days90th percentile
11clearances measured
FDA profile
- Official device name
- Implantable Transprostatic Tissue Retractor System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5530
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA definition
- The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
- Adverse events (MAUDE)
- 2021: 50 · 2022: 55 · 2023: 52 · 2024: 37 · 2025: 69 · 2026: 56
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UroLift 2 ATC Advanced Tissue Control System (K232558) | Neotract, Inc. | 2023-09-22 |
| UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (K201837) | Neotract, Inc. | 2020-07-31 |
| UroLift Advanced Tissue Control (ATC) System (K200441) | Neotract, Inc. | 2020-06-05 |
| UroLift System (UL400) (K193269) | Neotract, Inc. | 2019-12-20 |
| UroLift System UL400 (K190377) | Neotract, Inc. | 2019-03-21 |
| UroLift System (UL400 and UL500) (K173087) | Neotract, Inc. | 2017-12-28 |
| UroLift System (UL500) (K172359) | Neotract, Inc. | 2017-08-18 |
| UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (K162345) | Neotract, Inc. | 2016-09-21 |
| NeoTract UroLift System UL500 (K153584) | Neotract, Inc. | 2016-03-15 |
| NEOTRACT UROLIFT SYSTEM (K133281) | Neotract, Inc. | 2013-12-20 |
| UROLIFT SYSTEM (DEN130023) | Neotract, Inc. | 2013-09-13 |
Track PEW automatically
Every clearance here is in the API, with alerts when new ones post.