# K040148: Resolution Hemostasis Clipping Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 22, 2004 after 90 days
- Product code: MCH (Clip, Hemostatic)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963160 (1997). 3 ancestors in all.
48 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013066: HX-5/6-1 Endoscopic Clipping Device, Olympus America, Inc. (2001) Summary page 4.
- K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips, Olympus Optical, Co. (1999) Summary page 4.
- K963160: HX-5/6-1 Endoscopic Clipping Device, Olympus America, Inc. (1997) Summary page 4.

## Most influential descendants
- 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
- K152001: Sterile Repositionable Hemostasis Clipping Device (2015), 15 descendants of its own
- K161463: SureClip (TM) Repositionable Hemostasis Clip (2017), 13 descendants of its own

## Recalls of this device
- Jun 17, 2009 · Not classified · Z-1896-2009: The clip may not deploy or, if deployed, the clip may not release from the tissue.
- Jun 17, 2009 · Not classified · Z-1895-2009: The clip may not deploy or, if deployed, the clip may not release from the tissue.

## Indications for use
Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: - endoscopic marking - hemostasis for mucosal/submucosal defects <1cm, bleeding ulcers, arteries <2mm, polyps <1.5cm in diameter, diverticula in the colon - anchoring to affix jejunal feeding tubes to the wall of the small bowel - as a supplemental closure method of luminal perforations <20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K040148
Methodology: https://510kreport.com/methodology