# K220846: Core-Snare

- Pathway: 510(k) (Traditional)
- Applicant: Incore Co., Ltd.
- Decided: Nov 21, 2022 after 243 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K950496 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183289: ClearGrasp Snare, Finemedix Co., Ltd. (2019) Summary page 5.

## Indications for use
The CORE-SNARE is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Source page: https://510kreport.com/device/K220846
Methodology: https://510kreport.com/methodology