Pristine Surgical Gains 510(k) for Summit Single-Use Arthroscope

Pristine Surgical received FDA 510(k) clearance to market Summit, a first-of-its-kind 4K single-use surgical arthroscope designed to improve the efficiency, consistency and safety of arthroscopic procedures.

Pristine Surgical expects to launch Summit within 1Q23 with a transparent subscription pricing model and an automated re-ordering system.

Summit combines a 4K single-use surgical arthroscope with Pristine Connect™ cloud-based software to deliver a high-definition image. The scope is simple to set up and 100% sterile, ensuring patient and staff safety.

Pristine Surgical developed the Summit single-use arthroscope to address challenges with conventional surgical visualization systems, which can be complex and expensive, and feature reusable arthroscopes that are costly to maintain.

“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.”

Source: Pristine Surgical