# K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical, Co.
- Decided: Mar 26, 1999 after 25 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: 1 generation back to K963160 (1997). 1 ancestor in all.
57 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963160: HX-5/6-1 Endoscopic Clipping Device, Olympus America, Inc. (1997) Summary page 1.

## Most influential descendants
- K013066: HX-5/6-1 Endoscopic Clipping Device (2001), 53 descendants of its own
- K040148: Resolution Hemostasis Clipping Device (2004), 48 descendants of its own
- K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 (2012), 39 descendants of its own
- K142973: Resolution Clip (2014), 23 descendants of its own
- K151802: Resolution Clip (2015), 19 descendants of its own

## Indications for use
Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3cm, bleeding ulcers and arteries <2mm, polyps <1.5cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

Source page: https://510kreport.com/device/K990687
Methodology: https://510kreport.com/methodology