# K963160: HX-5/6-1 Endoscopic Clipping Device

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jun 27, 1997 after 317 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
No predicates in its family tree.
59 later devices descend from it; 4 cite it directly.
0 of 60 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) Olympus HX-2 Clipping Device: named in the summary without a submission number
- (no number) Olympus HX-3 Clipping Device: named in the summary without a submission number
- (no number) Olympus HX-4 Clipping Device: named in the summary without a submission number

## Most influential descendants
- K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips (1999), 57 descendants of its own
- 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

## Indications for use
The subject 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 <3 cm, bleeding ulcers and arteries <2 mm, polyps < 1.5 cm 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/K963160
Methodology: https://510kreport.com/methodology