# K193269: UroLift System (UL400)

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Dec 20, 2019 after 24 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: 6 generations back to DEN130023 (2013). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173087: UroLift System (UL400 and UL500), Neotract, Inc. (2017) Summary page 4.

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

## Recalls of this device
- Jun 24, 2022 · Class II · Z-1502-2022: There is the potential that during implant deployment, the device may not properly deliver a implant.

## 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/K193269
Methodology: https://510kreport.com/methodology