FDA

On May 24, 2013 GSquared Medical began 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. In the box for REGISTRATION or FEI Number  type in 301203589

The material used in the PH-25, Extender and HIPster retractors 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

The material used in the ABBy, ABBy Plus and DermaHug tissue stabilizers has been subjected to the following studies:

Silicone adhesive toxicology

Skin sensitization test

Genetic toxicity test

Biocompatibility

• Cytotoxicity
• Systemic toxicity
• Intracutaneous Reactivity
• Implantation
• Skin Sensitization
• Pyrogen