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510(k) K112782

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES by Misonix, Inc. — Product Code NRB

K112782 is an FDA 510(k) premarket notification submitted by Misonix, Inc. for the device "MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 1, 2011. The device falls under product code NRB (Wound Cleaner, Ultrasound), a Class II device regulated under 21 CFR 878.4410. Misonix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2011
Date Received
September 26, 2011
Clearance Type
Traditional
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

Other clearances by Misonix, Inc.

  • K221235 — neXus Ultrasonic Surgical Aspirator System (July 28, 2022)
  • K212060 — neXus Ultrasonic Surgical Aspirator System (December 13, 2021)
  • K190160 — neXus Ultrasonic Surgical Aspirator System (May 30, 2019)
  • K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (March 5, 2013)
  • K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (July 9, 2008)
  • K070313 — MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (May 11, 2007)
  • K062471 — ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (October 26, 2006)
  • K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (January 26, 2006)
  • K052702 — MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (November 21, 2005)
  • K050776 — AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (June 6, 2005)

Other clearances for product code NRB

  • K162721 — Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicato (December 22, 2016)
  • K140782 — ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLI (August 13, 2014)
  • K131096 — AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM (May 16, 2014)
  • K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (March 5, 2013)
  • K122246 — MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF (August 13, 2012)
  • K091038 — AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (June 19, 2009)
  • K050129 — CELLERATION MIST THERAPY SYSTEM 5.1 (May 17, 2005)
  • DEN040004 — CELLERATION MIST THERAPY SYSTEM (June 25, 2004)

FDA data resources