Summit Medical Nears Completion of 510(k) Goals with FDA Clearance for Additional Sterilization Cycles


The global infection control market is estimated to reach $16.7 billion by the year 2020 and one of the major drivers for this growth is the increase in occurrence of hospital-acquired infections. Healthcare facilities and medical devices play a vital role in this market and the need for regulated sterilization and disinfection techniques has risen greatly. Heat sterilization is the most widely used technique, but a majority of the growth is expected to be driven by the low-temperature sterilization market.

As low-temperature sterilization becomes more popular for delicate medical devices, the need for manufacturers to support these cycles has increased. Summit Medical, Inc. has recognized this trend and is constantly working to validate its InstruSafe® Instrument Protection Tray products for a variety of cycles to stay ahead of the curve. Sterilization technology will continue to improve, and Summit Medical’s efforts to obtain clearances for new cycles will remain ongoing.

“We have been steadfast in our strategy to obtain 510(k) clearances for popular sterilization modalities. Getting these two additional clearances shows our commitment to the continual development and improvement of our InstruSafe products. As we near our goal for FDA 510(k) clearances we will keep our focus and attention on any new sterilization cycles impacting the sterile processing industry,” says Marcus Super, director of InstruSafe sales and marketing.

• 4 minute Steam for use with Aesculap™ rigid container
• 4 minute Steam for use with Genesis® rigid container
• Ethylene Oxide
• STERRAD ® 100S
• STERRAD ® 100 NX Standard Cycle
• STERRAD ® 100 NX Express Cycle
• STERRAD ® 100 NX Flex

Summit Medical, Inc. also manufactures ENT products such as ventilation tubes, myringotomy blades and nasal splints along with many other surgical and non-surgical products. They also market proprietary products such as the EarPopper® Ear Pressure Relief Device, Dizzy FIX™ BPPV Training Device, and Silverstein MicroWick™ Drug Delivery System.

Source: Summit Medical, Inc.

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