# K193424: Resolution 360™ ULTRA Clip

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 1, 2020 after 266 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: 8 generations back to K963160 (1997). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151802: Resolution Clip, Boston Scientific Corporation (2015) Summary page 4.
- K182556: SureClip Repositionable Hemostasis Clip, Micro-Tech (Nanjing) Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K222503: Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (2022), 2 descendants of its own
- K253734: Taurus Clip (2026), 0 descendants of its own
- K250066: Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (2025), 0 descendants of its own
- K221124: MANTIS Clip (2022), 0 descendants of its own

## Indications for use
The Resolution 360 ULTRA Clip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: -Mucosal/sub-mucosal defects <3cm -Bleeding ulcers -Arteries <2mm -Polyps <1.5cm 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/K193424
Methodology: https://510kreport.com/methodology