# K964661: HX-20/21-1 Endoscopic Ligator

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Oct 30, 1997 after 344 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 its predicate without a number.
- (no number) Endoscopic Ligators by C.R. Bard: named in the summary without a submission number
- (no number) Endoscopic Ligators by Wilson-Cook: named in the summary without a submission number
- (no number) Endoscopic Ligators by Microvasive: named in the summary without a submission number

## Most influential descendants
- K172985: Ligation Device (2018), 0 descendants of its own
- K984255: Olympus HX-20 Series Ligating Device (1999), 0 descendants of its own

## Indications for use
The Olympus HX -20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop, designed to prevent or control bleeding following polypectomy of pedunculated polvps.

Source page: https://510kreport.com/device/K964661
Methodology: https://510kreport.com/methodology