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TMCNet:  Summit Medical, Inc. Receives FDA 510(k) Clearance for Additional Sterilization Cycles

[July 18, 2014]

Summit Medical, Inc. Receives FDA 510(k) Clearance for Additional Sterilization Cycles

ST. PAUL, Minn. --(Business Wire)--

Summit Medical, Inc., striving to maintain their top spot in the medical device industry has achieved yet another goal. They are amongst few in the marketplace to gain FDA clearance for sterilization methods on their state of the art instrument protection trays. These validations serve as a safeguard, to ensure the product will not inhibit sterility of valuable surgical instrumentation. And now, more sterilization cycles mean additional options for hospitals and health care centers.

"Instru-Safe® trays continue to be an industry leader for organizing and protecting surgical instrumentation. As part of our efforts to continually improve our unique product and differentiate ourselves in the market, we have gone through rigorous validation testing and multiple 510(k) submissions. We do this to ensure customer confidence in our instrument protection products and to demonstrate our commitment to the sterile processing community." Kevin McIntosh - Executive VP and COO of Summit Medical, Inc.


Instrument Protection Trays are used to organize and protect other medical devices that are sterilized by a healthcare provider. Summit's team of product developers, engineers and field representatives around the country work closely with hospitals and facilities to customize trays to meet the preferences of the surgical teams who use them on a daily basis.

Instru-Safe® Instrument Protection Trays are now cleared for the following cycles:

  • 4 minute Steam Sterilization Cycle
  • 8 minute Steam Sterilization Cycle
  • Ethylene Oxide
  • STERRAD ® 100S
  • STERRAD ® 100 NX Standard Cycle

Summit Medical, Inc. is a St. Paul, Minnesota based medical manufacturer that has been designing, engineering and manufacturing products for over 30 years. In addition to instrument protection trays, Summit Medical 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. From instrument protection trays to over-the-counter products, Summit Medical is consistently developing new technologies to meet industry demands. For more information on Summit Medical products, visit www.summitmedicalusa.com.


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