# K102764: Resolution II Clip

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 22, 2010 after 89 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Recalls of this device
- Jul 19, 2011 · Not classified · Z-3056-2011: Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resu

## Indications for use
The Resolution 11 Clip is indicated for clip placement within the Gastrointestinal 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 Anchoring to affix jejunal feeding tubes to the wall of the small bowel As a supplementary method for closure of GI tract luminal perforations <20mm that can be treated conservatively

Source page: https://510kreport.com/device/K102764
Methodology: https://510kreport.com/methodology