Healthcare Industry News:  reprocessing 

Devices Surgery FDA

 News Release - January 21, 2015

Summit Medical, Inc. Obtains Two More FDA Clearances in a Continuing Effort to Accommodate Customers

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--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 very 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 is an industry leader in terms of service and quality and with each additional FDA clearance comes more options for customers.

Summit Medical, Inc. continues to define itself in the marketplace by gaining FDA clearances for sterilization methods. Their 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,” said Marcus Super – Director of InstruSafe Sales and Marketing, Summit Medical, Inc.

“510(k) clearances continue to be a primary focus of our company with the InstruSafe brand,” stated 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® 100S
  • STERRAD® 100NX Standard Cycle
  • STERRAD® 100NX Express Cycle
  • 4 Minute Steam Cycle for use with popular rigid containers
Summit Medical, Inc. is a St. Paul, Minnesota based medical device 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.


Source: Summit Medical

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