Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)

Olympus Medical Systems Corporation

510k7/29/2025

FDA #

K251664

Product Code

KTI

Panel

Anesthesiology

Modality:Ultrasound Task:Detection Body Region:Chest

The Single Use Aspiration Needle models NA-201SX-4021 and NA-201SX-4022 by Olympus Medical Systems are sterile, disposable needles used alongside ultrasound endoscopes to perform fine needle aspiration of submucosal and extramural lesions in the tracheobronchial tree. They help clinicians obtain tissue samples safely and effectively under real-time ultrasound guidance.

Intended Use

Intended for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

Technology

The devices are single-use, sterile (Ethylene Oxide) aspiration needles designed to work with ultrasound endoscopes. Features include adjustable sheath lengths, specific needle gauges (21G and 22G), working length of 700mm, ultrasound visualization compatibility, and luer lock connectors.

Performance

Performance testing included insertion, piercing, ultrasound visibility, needle extraction/retraction, aspiration performance, and mechanical strength tests, all meeting acceptance criteria. Biocompatibility testing confirmed the device is safe for intended use. Sterilization testing validated endotoxin limits and sterility assurance; shelf-life testing confirmed a 3-year shelf life.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
5/30/2025
2 months
2
FDA Approval
7/29/2025

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