FDA grants clearance to World's First 4K Single-Use Surgical Arthroscope

The US Food and drug administration (FDA) has granted 510(k) clearance to Summit arthroscope, a single-use device that features 4K resolution for arthroscopic procedures. Pristine Surgical has received the clearance for world's first single-use surgical arthroscope.

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.”