# K180363: Clear-Tip EUS-FNA

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Nov 1, 2018 after 265 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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 K935844 (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)
- K142688: Echotip Procore HD Ultrasound Biopsy Needle, Cook Ireland, Ltd. (2014) Summary page 4.

## Indications for use
The Clear-Tip EUS-FNA is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Source page: https://510kreport.com/device/K180363
Methodology: https://510kreport.com/methodology