# K260580: Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: May 21, 2026 after 90 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- 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: 8 generations back to K963160 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240617: Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS), Olympus Medical Systems Corp. (2024) Summary page 5.

## Indications for use
The Single Use Reloadable Clip Applicators HX-810 Series, Clip HX-610 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (Gl) tract in adult patients only for the purpose of: (1) Endoscopic marking, (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3 cm, (b) Bleeding ulcers, (c) Arteries <2 mm, (d) Polyps < 1.5 cm in diameter, (e) Diverticula in the colon, (3) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treated conservatively.

Source page: https://510kreport.com/device/K260580
Methodology: https://510kreport.com/methodology