# K183021: ClearEndoclip

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Jun 28, 2019 after 239 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: 4 generations back to K963160 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123601: Single Use Repositionable Clip, Olympus Medical Systems Corp. (2013) Summary page 4.

## Most influential descendants
- K213338: Core-Clip (2022), 0 descendants of its own
- K200217: ClearEndoclip (2020), 0 descendants of its own

## Indications for use
ClearEndoclip 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) Anchoring to affix jejunal feeding tubes to the wall of the small bowel (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively

Source page: https://510kreport.com/device/K183021
Methodology: https://510kreport.com/methodology