Pristine Surgical receives FDA 510(k) clearance for 4K resolution single-use arthroscope
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Pristine Surgical has announced FDA 510(k) clearance of the Summit arthroscope, a single-use device that features 4K resolution for arthroscopic procedures, according to a company press release.
The Summit arthroscope, which utilizes Pristine Surgical’s cloud-based software Pristine Connect, is designed to deliver surgeons enhanced viewing with 4K resolution, according to the release.
“The Summit single-use arthroscope represents a new paradigm in arthroscopy, improving a procedure that hasn’t changed much in my 42 years of practice and beyond,” Stephen J. Snyder, MD, chief medical officer of Pristine Surgical, said in the release. “We’re removing the well-known barriers of legacy, reusable systems that eventually become obsolete by offering a new 4K single-use scope that improves safety and reliability while decreasing room turnover time and the cost of arthroscopic treatment,” Snyder said.
“Summit simplifies arthroscopic procedures, offering a fully integrated single-use scope with 4K resolution that’s one of a kind,” Bryan Lord, CEO of Pristine Surgical, said in the release. “Our FDA clearance is a significant milestone for the company. More importantly, it means that we can now begin offering the benefits of these single-use devices to surgeons and staff, and bring our single-use, cloud-based platform to more than 125 million endoscopy patients treated worldwide each year,” Lord added.
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