# K023272: Disposable Aspiration Needle NA-200H

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Dec 23, 2002 after 83 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904667 (1990). 4 ancestors in all.
63 later devices descend from it; 4 cite it directly.
1 of 68 devices in its family (counting itself) has 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.
- K994253: Vaclok Syringe, Merit Medical Systems, Inc. (2000) Summary page 1.
- K934123: Stopcock (One-Port Manifold), Merit Medical Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-1069-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

## Indications for use
This instrument has been designed to be used with the 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/K023272
Methodology: https://510kreport.com/methodology