# K160098: Single Use Aspiration Needle NA-U401SX

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 22, 2016 after 63 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894632 (1989). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050503: Single Use Aspiration Needle NA-201SX-4022, Olympus Medical Systems Corporation (2005) Summary page 5.

## Most influential descendants
- K180668: Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (2018), 0 descendants of its own

## Recalls of this device
- Mar 31, 2023 · Class III · Z-1615-2023: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and r
- Mar 31, 2023 · Class III · Z-1616-2023: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and r

## 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 tracheobronchial tree and the gastrointestinal tract.

Source page: https://510kreport.com/device/K160098
Methodology: https://510kreport.com/methodology