# K142973: Resolution Clip

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 1, 2014 after 48 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: 5 generations back to K963160 (1997). 5 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612, Boston Scientific Corporation (2012) Summary page 1.

## Most influential descendants
- K151802: Resolution Clip (2015), 19 descendants of its own
- K202333: Lockado Repositionable Hemostasis Clip (2021), 7 descendants of its own
- K182556: SureClip Repositionable Hemostasis Clip (2018), 6 descendants of its own
- K193424: Resolution 360™ ULTRA Clip (2020), 4 descendants of its own
- K222503: Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (2022), 2 descendants of its own

## Indications for use
The Resolution Hemostasis Clipping Device is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: Mucosal/sub-mucosal defects <3 cm Bleeding ulcers Arteries <2 mm Polyps < 1.5 cm in diameter Diverticula in the colon Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

Source page: https://510kreport.com/device/K142973
Methodology: https://510kreport.com/methodology