# DEN130023: Urolift System

- Pathway: De Novo (Direct)
- Applicant: Neotract, Inc.
- Decided: Sep 13, 2013 after 190 days
- Product code: PEW (Implantable Transprostatic Tissue Retractor System)
- Device class: 2
- Regulation: 21 CFR 876.5530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K133281: Neotract Urolift System (2013), 9 descendants of its own
- K153584: NeoTract UroLift System UL500 (2016), 8 descendants of its own
- K162345: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (2016), 7 descendants of its own
- K172359: UroLift System (UL500) (2017), 6 descendants of its own
- K173087: UroLift System (UL400 and UL500) (2017), 5 descendants of its own

Source page: https://510kreport.com/device/DEN130023
Methodology: https://510kreport.com/methodology