# K083556: Modification to Auto-Band Ligator

- Pathway: 510(k) (Special)
- Applicant: Scandimed International
- Decided: Feb 19, 2009 after 79 days
- Product code: MND (Ligator, Esophageal)
- 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: 2 generations back to K031236 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031236: Auto-Band Ligator, Scandimed. A.S. (2003) Summary page 1.
- K081142: Auto-Band Ligator, Scandimed International (2008) Summary page 1.

## Most influential descendants
- K132535: Autoband Ligator (2013), 0 descendants of its own

## Indications for use
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

Source page: https://510kreport.com/device/K083556
Methodology: https://510kreport.com/methodology