510(k) K122246
K122246 is an FDA 510(k) premarket notification submitted by Celleration, Inc. for the device "MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12". The FDA issued a decision of Substantially Equivalent on August 13, 2012. The device falls under product code NRB (Wound Cleaner, Ultrasound), a Class II device regulated under 21 CFR 878.4410. Celleration, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2012
- Date Received
- July 27, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Cleaner, Ultrasound
- Device Class
- Class II
- Regulation Number
- 878.4410
- Review Panel
- SU
- Submission Type
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