# K151802: Resolution Clip

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 6, 2015 after 35 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: 6 generations back to K963160 (1997). 6 ancestors in all.
19 later devices descend from it; 7 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142973: Resolution Clip, Boston Scientific Corporation (2014) Summary page 4.

## Most influential descendants
- 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
- K212748: Disposable Dual Action Tissue Clip (2022), 2 descendants of its own

## Indications for use
The Resolution 360 Clip is indicated for placement in the Gastrointestinal tract for: 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/K151802
Methodology: https://510kreport.com/methodology