NRB

9 FDA 510(k) clearances · Product code

FDA profile

Official device name

Wound Cleaner, Ultrasound

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4410

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

FDA definition

The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound

Adverse events (MAUDE)

2006: 3 · 2007: 3 · 2008: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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