On May 24, 2013 the FDA issued clearance to market the Retentus line of retractors as a Class 1 510(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 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: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm.
The purpose of this medical device is to position the patient during surgery or other medical procedures.
The material used in the retractor has been subjected to the following safety evaluations:
In Vitro Cytotoxicity
Primary Skin Irritation
Guinea Pig Sensitization
- Repeated Insult Patch Test (Draize) in Humans
- 21-day Cumulative Irritation in Humans