# K181994: Single Use Aspiration Needle NA-U201H

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 31, 2018 after 97 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: 7 generations back to K904667 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151738: Single Use Aspiration Needle NA-U200H, Olympus Medical Systems Corp. (2015) Summary page 5.

## Indications for use
These instruments have been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

Source page: https://510kreport.com/device/K181994
Methodology: https://510kreport.com/methodology