# K970563: Olympus NA-10J-1 Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Apr 11, 1997 after 57 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: 1 generation back to K904667 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904667: NA Needles, Olympus Corp. (1990) Summary page 1.

## Indications for use
The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) within the gastrointestinal tract.

Source page: https://510kreport.com/device/K970563
Methodology: https://510kreport.com/methodology