Skip to content
Scan

Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K163469

ViziShot 2 FLEX · Olympus Surgical Technologies America · decided 2017-04-06 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ViziShot 2 FLEXNA-U403SX-4019Gyrus ACMI, LLCKTI00821925043060