Symmetry Medical Inc has received 510(k) clearance from the U.S. Food and Drug Administration for its entire line of PolyVac Surgical Instrument Delivery Systems (cases and trays). The clearance applies to all of the company's standard plastic, metal and hybrid cases and trays, including Minitainer, Modultainer, OptiCare, LapCare and Universal Trays, to name a few.
Symmetry received its clearance under proposed guidelines set forth by FDA for Medical Sterilization Packaging Systems. All steam sterilization testing was conducted by a certified independent third party steam sterilization laboratory in accordance with established guidelines.
"This clearance represents a major accomplishment for Symmetry Medical and most likely will establish a precedent for future 510(k) submissions for medical delivery systems (cases and trays)," noted Darin Martin, Vice President, Quality/Regulatory for Symmetry. "Many other case and tray manufacturers have received clearance for some of their products, but none has received comprehensive 510(k) clearance for a full line of standard case and tray products. This clearance attests to Symmetry's confidence in its products and its continued commitment to assuring that we provide our customers with safe and effective products on the market."