# K180668: Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Nov 15, 2018 after 246 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: 10 generations back to K894632 (1989). 56 ancestors in all.
No later device cites it as a predicate yet.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160098: Single Use Aspiration Needle NA-U401SX, Olympus Medical Systems Corp. (2016) Summary page 5.

## Indications for use
This instrument has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration(FNA) of submucosal and extramural lesions of the gastrointestinal tract.

Source page: https://510kreport.com/device/K180668
Methodology: https://510kreport.com/methodology