# K232558: UroLift 2 ATC Advanced Tissue Control System

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Sep 22, 2023 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: 7 generations back to DEN130023 (2013). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201837: UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge, Neotract, Inc. (2020) 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/K232558
Methodology: https://510kreport.com/methodology