# K963166: O'regan Ligator

- Pathway: 510(k) (Traditional)
- Applicant: Patrick J. O'Regan
- Decided: May 5, 1997 after 264 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070881: Lem Hemorrhoidal Ligator, Models a.5650, a.5660 (2007), 4 descendants of its own
- K091519: Haemoband Multi-Ligator (2009), 3 descendants of its own
- K131282: Nexus Hemorrhoid Ligator (2013), 1 descendant of its own
- K150718: Wi-3 HAL-RAR System (2015), 0 descendants of its own
- K093497: THD Bandy (2010), 0 descendants of its own

## Indications for use
This ligator is intended to be used only as a hemorrhoid ligator.

Source page: https://510kreport.com/device/K963166
Methodology: https://510kreport.com/methodology