# K991672: Olympus NA-10J-KB Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 3, 1999 after 170 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: 2 generations back to K904667 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973128: Olympus NA-10J-1 Aspiration Needle, Olympus America, Inc. (1997) Summary page 1.

## Indications for use
This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, peri-rectal masses and lymph nodes).

Source page: https://510kreport.com/device/K991672
Methodology: https://510kreport.com/methodology