VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR

VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR is an FDA 510(k)-cleared medical device (K072073) manufactured by Vision-Sciences, Inc.. 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 August 28, 2007. Regulation: 8.