# K973128: Olympus NA-10J-1 Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 18, 1997 after 89 days
- Product code: FOG (Hood, Oxygen, Infant)
- Device class: 1
- Regulation: 21 CFR 868.5700
- 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.
65 later devices descend from it; 3 cite it directly.
1 of 67 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K023272: Disposable Aspiration Needle NA-200H (2002), 63 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K100712: Resound Endoscopic Ultrasound Aspiration Needle (2010), 27 descendants of its own
- K110030: Expect Endoscopic Aspiration Needle (2011), 26 descendants of its own
- K112198: Expect Endoscopic Ultrasound Aspiration Needle (2011), 16 descendants of its own

## 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) 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/K973128
Methodology: https://510kreport.com/methodology