FDA-Device2025-09-17Class I
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Olympus Corporation of the Americas
Hazard
Potential for undetected, deformed a-traumatic tips.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
Affected count
104,508 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2484-2025Don't want to check this manually?
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