Misonix Submits 510(k) for Ultrasonic Wound Debrider

Misonix, a developer of ultrasonic medical device technology for the treatment of cancer and other healthcare purposes, has filed a 510(k) application with the FDA for clearance to market its Ultrasonic Wound Debridement System.

The device already has approval through a previous filing of a 510(k) application pertaining to soft tissue aspiration. The filing was accompanied by the results from recent clinical studies conducted in Italy. Separately, Misonix said it achieved positive results from clinical studies for its wound debrider at the Wound Care Center at Tempe St. Luke's Hospital in Tempe, Ariz.

The FDA's review of the 510(k) application for the wound debridement may take 90 days or fewer to approve, and may require the furnishing of additional information that is then subject to another review period of up to 90 days. The entire process, timing and results of 510(k) reviews will be determined solely by the FDA.