HospitalsRegulatory

Pristine Surgical Receives FDA 510(k) Clearance for Summit™, the World’s First 4K Single-Use Surgical Arthroscope

Designed to Improve Procedure Efficiency, Consistency, and Safety

January 5, 2023

MANCHESTER, N.H.–(BUSINESS WIRE)–Medical device company Pristine Surgical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Summit, a first-of-its-kind 4K single-use surgical arthroscope designed to improve the efficiency, consistency, and safety of arthroscopic procedures.

Summit combines a 4K single-use surgical arthroscope with cloud-based software – Pristine Connect™ – to deliver a high-definition image, every time, with a device that is always new and never obsolete. The scope is simple to set up and 100% sterile, ensuring patient and staff safety. Its transparent pricing model and automated inventory management also improve predictability and workflow.

“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,” said Dr. Stephen Snyder, chief medical officer of Pristine Surgical and a recognized pioneer in the field of arthroscopy. “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.”

Pristine Surgical developed the Summit single-use arthroscope to address challenges inherent to conventional surgical visualization, which are complex and expensive, and feature reusable arthroscopes that are difficult and costly to maintain. Prone to wear, damage, and potential infection, these scopes can bring inefficiency and variability into the operating room.

“Summit simplifies arthroscopic procedures, offering a fully integrated single-use scope with 4K resolution that’s one-of-a-kind,” said Bryan Lord, CEO of Pristine Surgical. “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.”

Pristine Surgical expects to launch the Summit single-use arthroscope during the first quarter of 2023 with a predictable and transparent subscription pricing model and a convenient, automated re-ordering system. Through industry leading sustainability partnerships, Pristine Surgical will also provide recycling options to its customers.

About Pristine Surgical

Pristine Surgical is a medical device company with a mission to simplify endoscopy. The company combines single-use endoscopes with cloud-based software to make minimally invasive visualization more efficient, consistent, and safe. Pristine Surgical offers a subscription business model with transparent pricing and automated inventory management, delivering improved workflow and reduced costs to the endoscopy suite. For more information, visit pristinesurgical.com, or find the company on LinkedIn.

Contacts

Sam Choinski
Pazanga Health Communications
schoinski@pazangahealth.com
(860) 301-5058

Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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