# K984255: Olympus HX-20 Series Ligating Device

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp of America
- Decided: Jan 12, 1999 after 43 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: 1 generation back to K964661 (1997). 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)
- K964661: HX-20/21-1 Endoscopic Ligator, Olympus America, Inc. (1997) Summary page 1.

## Indications for use
Olympus HX-20-1 Ligating device 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 polyps.

Source page: https://510kreport.com/device/K984255
Methodology: https://510kreport.com/methodology