# K250994: ClearTip FNA and FNB Types

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Aug 21, 2025 after 142 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: 12 generations back to K894632 (1989). 62 ancestors in all.
No later device cites it as a predicate yet.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231267: ClearTip, Finemedix Co., Ltd. (2023) Summary page 5.

## Indications for use
The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

Source page: https://510kreport.com/device/K250994
Methodology: https://510kreport.com/methodology