# K252646: Single-Use Fine Needle Biopsy (FNB) device  (NA-U210H)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 24, 2025 after 64 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: 8 generations back to K904667 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180449: Single Use Aspiration Needle NA-U200H, Olympus Medical Systems Corp. (2018) Summary page 6.

## Indications for use
The Single-use Fine Needle Biopsy (FNB) device NA-U210H has been designed to be used with an ultrasound endoscope for sampling of submucosal and extramural lesions within or adjacent the gastrointestinal tract.

Source page: https://510kreport.com/device/K252646
Methodology: https://510kreport.com/methodology