# K213223: Multi-Band Ligator

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Zksk Technology Co., Ltd.
- Decided: Jun 6, 2022 after 250 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 K974018 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974018: Wilson-Cook 10 Shot Multi-Band Ligator, Wilson-Cook Medical, Inc. (1998) Summary page 4.

## Indications for use
Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Source page: https://510kreport.com/device/K213223
Methodology: https://510kreport.com/methodology