# K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 3, 2012 after 94 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: 4 generations back to K963160 (1997). 4 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040148: Resolution Hemostasis Clipping Device, Boston Scientific Corp (2004) Summary page 1.

## Most influential descendants
- 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
- K172727: Hemoclip (2018), 8 descendants of its own

## Indications for use
The Resolution™ Hemostasis Clipping Device is indicated for use endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic Marking 2. Hemostasis for; Mucosal/sub-mucosal defects < 3cm Bleeding ulcers Arteries < 2cm Polyps <1.5cm in diameter o Diverticula in the colon 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplemental closure method of luminal perforations <20mm that can be treated conservatively.

Source page: https://510kreport.com/device/K122660
Methodology: https://510kreport.com/methodology