Flexible Intubation Video Endoscope – Sterile (FIVE-S)

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is an FDA 510(k)-cleared medical device (K212656) manufactured by Karl Storz Endoscopy America. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2021. Regulation: 8.