# K153584: NeoTract UroLift System UL500

- Pathway: 510(k) (Traditional)
- Applicant: Neotract, Inc.
- Decided: Mar 15, 2016 after 91 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: 2 generations back to DEN130023 (2013). 2 ancestors in all.
8 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)
- DEN130023: Urolift System, Neotract, Inc. (2013) Summary page 4.
- K133281: Neotract Urolift System, Neotract, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- 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

## Indications for use
UroLift® System is intended for the 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/K153584
Methodology: https://510kreport.com/methodology