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Safety

Safety

There is virtually no risk of allergic reaction. The Selphyl® System is used to rapidly collect and isolate a patient’s own PRP for injection and contains no animal or synthetic products.
 

There have been no known side effects associated with Selphyl® reported to date. As with any injectable procedure, some patients may experience some mild and temporary irritation, swelling, bruising, itching, discoloration or tenderness at the injection site.
 

The Selphyl® System was cleared for marketing under premarket notification (510(k)) submission numbers BK120009 and BK120008. Factor Medical, LLC in conjunction with Cascade Medical Enterprises, LLC markets the FIBRINET® Autologous Fibrin & Platelet System in the U.S. under the trade name Selphyl® PRFM. The CE mark certification has been granted in Europe.
 

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You are now entering the international portion of the website that has not been evaluated by the United States Food and Drug Administration. Information shown on the site may describe clearances in countries other than the United States, and therefore may contain indications and uses that are outside the scope of the FDA-cleared labelling. Information shown on this website is not intended to diagnose, treat, cure or prevent disease. Information on the product, packaging and publications is for informational purposes only and is not intended as a substitution for advice from a physician or health-care professional.