# K213338: Core-Clip

- Pathway: 510(k) (Traditional)
- Applicant: Incore Co., Ltd.
- Decided: Jun 23, 2022 after 259 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: 5 generations back to K963160 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183021: ClearEndoclip, Finemedix Co., Ltd. (2019) Summary page 4.

## Indications for use
It is intended to be used with FDA-cleared endoscope for endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for (1) Endoscopic marking (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3cm (b) Bleeding ulcers (c) Arteries < 2 mm (d) Polyps < 1.5 cm in diameter (e) Diverticula in the colon (3) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively

Source page: https://510kreport.com/device/K213338
Methodology: https://510kreport.com/methodology