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GSquared Medical
FDA
FDA
On May 24, 2013 the FDA cleared GSquared Medical to market the Retentus   line of retractors as a Class I 510(k) exempt medical device.  Our registration number is 3010203589.  

Class I medical device is defined below:  

   Class I medical devices present minimal potential for harm to the user     Class I medical devices present minimal potential for harm to the Class I medical devices present minimal potential for harm to the and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining. 

For more information about Class I devices, please refer to the FDA website.




Click here to view our FDA registration, then click on 
ESTABLISHMENT 
then  type
GSquared Medical  
Retractor/Patient Positioning Device
   Registration number: 3010203589
   Product Classification Code: CCX
   Regulation Number: 868.6820

Wound Care/Wound Exposure Device
   Registration number: 3010203589
   Product Classification Code: MHW  
   Regulation Number: 880.5075

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The material used in the retractor has been subjected to the following safety evaluations:  





In Vitro Cytotoxicity
MEM Elution
Primary Skin Irritation
Guinea Pig Sensitization
  Repeated Insult Patch Test (Draize) in Humans
  21-day Cumulative Irritation in Humans