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510(k) K162721

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator by Alliqua Biomedical, Inc. — Product Code NRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2016
Date Received
September 29, 2016
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

Other clearances by Alliqua Biomedical, Inc.

  • K171041 — SilverSeal (August 22, 2017)

Other clearances for product code NRB

  • 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)
  • K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (December 1, 2011)
  • 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)