FDA Clears InstruSafe Instrument Protection System for Use in Sterizone® VP4 Sterilization Cycle I
ST. PAUL, Minn.–(BUSINESS WIRE)–Innovia Medical is pleased to announce the Sterizone VP4 sterilization process has been cleared by the United States Food and Drug Administration (FDA), (510(k) number, K210836.
The Sterizone VP4 Sterilization System offers a low temperature sterilization system which can quickly process high volumes of heat and moisture-sensitive devices using vaporized hydrogen peroxide, an environmentally friendly sterilant.
“The demand for a low temperature sterilizer offers an alternative for today’s advanced surgical tools which cannot tolerate high temperature sterilizers. Sterizone VP4 is the solution of choice,” said Aaron Lieberman, Director of Sales and Marketing, Innovia Medical.
InstruSafe Instrument Protection Trays provide 360 degrees of protection during sterilization and subsequent transportation and storage. The trays are validated for steam and low temperature sterilization cycles and are available in any shape or size.
InstruSafe Trays have 510(k) Clearance for each sterilization cycle. View the clearance here.
Innovia Medical is a family of specialty surgical companies that are passionately committed to partnering with medical professionals to help elevate the delivery of patient care and improve clinical outcomes.
Innovia Medical companies develop, and manufacture solutions designed to deliver quality care. Our goal is to save time for both the medical professional and patient, provide a consistent and predictable care experience, and improve patient confidence with reduced recovery times and minor discomfort.
Innovia’s mission is to improve outcomes for the global healthcare community and the patients they serve through innovative solutions that elevate the delivery of care.
Summit Medical, headquartered in St. Paul, Minnesota, is a medical device manufacturer serving the global healthcare community for over 35 years. The company is committed to staying on top of industry demands and developing solutions to meet them through design, engineering, and manufacturing stages.
Summit Medical works closely with surgeons, nurses, and allied healthcare professionals to develop unique, patented products that improve surgical outcomes and make the delivery of healthcare more efficient. Most Summit Medical products are manufactured and packaged in-house and sold by a global network of independent specialty distributors supported with a complete marketing program.
Contacts
Jen Hedtke
651.789.8166
jhedtke@innoviamedical.com