# K150718: Wi-3 HAL-RAR System

- Pathway: 510(k) (Traditional)
- Applicant: Agency For Medical Innovations GmbH
- Decided: Jun 12, 2015 after 85 days
- Product code: FHN (Ligator, Hemorrhoidal)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930458 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061831: Medchannel HTS System, Medchannel, LLC (2006) Summary page 5.
- K081429: THD Slide, Thd Spa (2008) Summary page 5.
- K131282: Nexus Hemorrhoid Ligator, Inx Medical (2013) Summary page 5.

## Indications for use
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.

Source page: https://510kreport.com/device/K150718
Methodology: https://510kreport.com/methodology