# K050503: Single Use Aspiration Needle NA-201SX-4022

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: May 12, 2005 after 73 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894632 (1989). 54 ancestors in all.
28 later devices descend from it; 6 cite it directly.
2 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042140: Olympus BF Type UC160-OL8, Olympus Corporation (2004) Summary page 2.
- K994253: Vaclok Syringe, Merit Medical Systems, Inc. (2000) Summary page 2.
- K934123: Stopcock (One-Port Manifold), Merit Medical Systems, Inc. (1993) Summary page 2.
- K023272: Disposable Aspiration Needle NA-200H, The Olympus Optical Co. (2002) Summary page 2.

## Most influential descendants
- K093195: Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O (2010), 8 descendants of its own
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own
- K142909: Flexible 19G EBUS Needle (2015), 7 descendants of its own
- K152922: ViziShot FLEX (2016), 6 descendants of its own
- K163469: ViziShot 2 FLEX (2017), 5 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-1060-2021: 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.
- Jan 4, 2021 · Class II · Z-1062-2021: 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.
- Jan 4, 2021 · Class II · Z-1059-2021: 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.
- Jan 4, 2021 · Class II · Z-1061-2021: 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.
- Aug 25, 2011 · Not classified · Z-0029-2012: Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial

## Indications for use
This instrument has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.

Source page: https://510kreport.com/device/K050503
Methodology: https://510kreport.com/methodology