The US Food and Drug Administration (FDA) has granted 510(k) clearance to Summit Medical for sterilisation methods on its Instru-Safe instrument protection trays.

Currently, the Instru-Safe instrument protection trays are approved for the four-minute steam sterilisation cycle, eight-minute steam sterilisation cycle, ethylene oxide, Sterrad 100S and Sterrad 100 NX standard cycle.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The company said that the validations serve as a safeguard, to ensure the product will not inhibit sterility of surgical instrumentation.

Approval of more sterilisation cycles provides additional options for hospitals and health care centres.

"We have gone through rigorous validation testing and multiple 510(k) submissions."

Summit Medical executive vice president and COO Kevin McIntosh said: "Instru-Safe trays continue to be an industry leader for organizing and protecting surgical instrumentation.

See Also:

"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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"We do this to ensure customer confidence in our instrument protection products and to demonstrate our commitment to the sterile processing community."

The instrument protection trays are used to organise and protect other medical devices that are sterilised by a healthcare provider.

In order to customise trays to meet the preferences of the surgical teams who use them on a daily basis, the company’s team of product developers, engineers and field representatives around the country work closely with hospitals and facilities, according to Summit.

As well as instrument protection trays, the company also manufactures ENT products such as ventilation tubes, myringotomy blades and nasal splints, along with many other surgical and non-surgical products.

The company also markets proprietary products including the EarPopper Ear Pressure Relief Device, Dizzy FIX BPPV Training Device, and Silverstein MicroWick Drug Delivery System.