# K180449: Single Use Aspiration Needle NA-U200H

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jun 8, 2018 after 108 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K252646: Single-Use Fine Needle Biopsy (FNB) device  (NA-U210H) (2025), 0 descendants of its own

## Indications for use
This instrument has been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration(FNA) and fine needle biopsy (FNB) 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/K180449
Methodology: https://510kreport.com/methodology