Misonix Receives FDA Clearance for Ultrasonic Wound Debrider

The FDA cleared devicemaker Misonix's Ultrasonic Wound Debridement System for the specific purpose of wound debridement, based upon the 510(k) application with the FDA.

The device previously received clearance through an earlier 510(k) filing with the FDA for use in soft tissue aspiration, but this was not for the specific purpose of wound debridement.

Wound debridement is a course of therapy to remove necrotic tissue or foreign material from a wound to expose healthy tissue. Studies have shown use of the system resulted in better granulation of the wound bed with minimal or no bleeding at the wound site.