FDA.reportPublic FDA data

510(k) K162721

Device
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
Applicant
ALLIQUA BIOMEDICAL, INC.
510(k) number
K162721
Product code
NRB  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-22
Date received
2016-09-29
Regulation
878.4410
Classification name
Wound Cleaner, Ultrasound
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHY SIMPSON
Address
11495 Valley View Rd. Eden Prairie MN US 55344 55344

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NRB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140782ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATORCelleration, Inc.2014-08-13
K131096AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEMArobella Medical, LLC2014-05-16
K123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.2013-03-05
K122246MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12Celleration, Inc.2012-08-13
K112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.2011-12-01
K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMArobella Medical, LLC2009-06-19
K050129CELLERATION MIST THERAPY SYSTEM 5.1Celleration, Inc.2005-05-17
DEN040004CELLERATION MIST THERAPY SYSTEMCelleration2004-06-25

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases