Summit Medical, Inc. Obtains Two More FDA Clearances


As technology advances, so does the complexity of medical devices, increasing the difficulty associated with sterilization procedures. Understanding the varying needs of the end user is something that Summit Medical, Inc. takes seriously. This key component is a driving force in Summit Medical’s plan to obtain further 510(k) clearances throughout 2015 for sterilization cycles on their InstruSafe® Instrument Protection Trays. Now with seven cleared sterilization cycles, Summit Medical remains committed to continuous product development and validation testing.

Summit Medical, Inc. continues to define itself in the marketplace by gaining FDA clearances for sterilization methods. The company's newest 510(k) clearances are for STERRAD® 100NX Express Cycle which enables fast turnaround for products such as endoscopes used for robotic surgery and a 4 Minute Steam Cycle for use with popular rigid containers. Summit is one of only a handful of tray manufacturers to receive express cycle clearance, differentiating them from competitors.

“Validation testing is a high priority. Our staff, including myself, has worked in sterile processing and the operating room in multiple capacities. This shared experience provides a sincere obligation to provide a product that is safe to use, offers our customers an array of sterilization cycles for reprocessing, and gives them an unmatched level of protection for their instrumentation,” says Marcus Super, director of InstruSafe sales and marketing for Summit Medical, Inc.

“510(k) clearances continue to be a primary focus of our company with the InstruSafe brand,” adds Kevin McIntosh, president of Summit Medical, Inc.

With the addition of two recent clearances, Summit Medical has authorized use of its InstruSafe Instrument Protection Trays for the following cycles:
• 4 Minute Steam Sterilization Cycle
• 8 Minute Steam Sterilization Cycle
• Ethylene Oxide
• STERRAD® 100NX Standard Cycle
• STERRAD® 100NX Express Cycle
• 4 Minute Steam Cycle for use with popular rigid containers

Source: Summit Medical, Inc.

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