# K173087: UroLift System (UL400 and UL500)

- Pathway: 510(k) (Traditional)
- Applicant: Neotract, Inc.
- Decided: Dec 28, 2017 after 90 days
- Product code: PEW (Implantable Transprostatic Tissue Retractor System)
- Device class: 2
- Regulation: 21 CFR 876.5530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN130023 (2013). 5 ancestors in all.
5 later devices descend from it; 3 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)
- K133281: Neotract Urolift System, Neotract, Inc. (2013) Summary page 4.
- K172359: UroLift System (UL500), Neotract, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K200441: UroLift Advanced Tissue Control (ATC) System (2020), 0 descendants of its own
- K190377: UroLift System UL400 (2019), 0 descendants of its own

## Recalls of this device
- Jul 6, 2018 · Class II · Z-0598-2019: Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Fail

## Indications for use
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.

Source page: https://510kreport.com/device/K173087
Methodology: https://510kreport.com/methodology