# K151738: Single Use Aspiration Needle NA-U200H

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Nov 20, 2015 after 147 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: 6 generations back to K904667 (1990). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023272: Disposable Aspiration Needle NA-200H, The Olympus Optical Co. (2002) Summary page 5.
- K973128: Olympus NA-10J-1 Aspiration Needle, Olympus America, Inc. (1997) Summary page 5.
- K112198: Expect Endoscopic Ultrasound Aspiration Needle, Boston Scientific Corporation (2011) Summary page 5.

## Most influential descendants
- K180449: Single Use Aspiration Needle NA-U200H (2018), 1 descendant of its own
- K252646: Single-Use Fine Needle Biopsy (FNB) device  (NA-U210H) (2025), 0 descendants of its own
- K181994: Single Use Aspiration Needle NA-U201H (2018), 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) 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/K151738
Methodology: https://510kreport.com/methodology