# K162345: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Sep 21, 2016 after 30 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
Longest line of descent: 3 generations back to DEN130023 (2013). 3 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K153584: NeoTract UroLift System UL500, Neotract, Inc. (2016) Summary page 4.

## Most influential descendants
- K172359: UroLift System (UL500) (2017), 6 descendants of its own
- K173087: UroLift System (UL400 and UL500) (2017), 5 descendants of its own
- K201837: UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (2020), 1 descendant of its own
- K193269: UroLift System (UL400) (2019), 1 descendant of its own
- K232558: UroLift 2 ATC Advanced Tissue Control System (2023), 0 descendants of its own

## Indications for use
UroLift System is intended for treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.

Source page: https://510kreport.com/device/K162345
Methodology: https://510kreport.com/methodology