# K070881: Lem Hemorrhoidal Ligator, Models a.5650, a.5660

- Pathway: 510(k) (Traditional)
- Applicant: Sapimed S.P.A.
- Decided: Sep 26, 2007 after 180 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: 1 generation back to K963166 (1997). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963166: O'regan Ligator, Patrick J. O'Regan (1997) Summary page 1.
- K000297: Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod. Erchinger, Erchinger Medizintecnik (2000) Summary page 1.

## Most influential descendants
- 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
The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.

Source page: https://510kreport.com/device/K070881
Methodology: https://510kreport.com/methodology