# PEW: Implantable Transprostatic Tissue Retractor System

- Device class: 2; regulation: 21 CFR 876.5530; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 30 days (middle half 30–30)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2016: 2
- 2017: 2
- 2019: 2
- 2020: 2
- 2023: 1

## Most-cited predicates
- K173087: UroLift System (UL400 and UL500) (2017), cited by 3
- DEN130023: Urolift System (2013), cited by 2
- K133281: Neotract Urolift System (2013), cited by 2
- K193269: UroLift System (UL400) (2019), cited by 1
- K162345: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (2016), cited by 1
- K172359: UroLift System (UL500) (2017), cited by 1
- K201837: UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (2020), cited by 1
- K153584: NeoTract UroLift System UL500 (2016), cited by 1

Source page: https://510kreport.com/product-code/PEW
Data by year (CSV): https://510kreport.com/product-code/PEW.csv