# K190377: UroLift System UL400

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Mar 21, 2019 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: 6 generations back to DEN130023 (2013). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.

## 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/K190377
Methodology: https://510kreport.com/methodology