# K221124: MANTIS Clip

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 4, 2022 after 108 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: 9 generations back to K963160 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K193424: Resolution 360™ ULTRA Clip, Boston Scientific Corporation (2020) Summary page 4.

## Indications for use
The MANTIS 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 <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/K221124
Methodology: https://510kreport.com/methodology