Pristine Surgical’s Single-Use Arthroscope Cleared

The FDA has granted 510(k) clearance to Pristine Surgical’s single-use Summit surgical arthroscope that delivers a high definition 4K image to cloud-based software.

The sterile, single-use device “represents a new paradigm in arthroscopy” and will eventually make reusable systems obsolete, the company claims, noting that reusable endoscopes are “complex, expensive and difficult to maintain.”

The product’s cloud-based software enables automated inventory management, image storage, video sharing and checklists for training staff.

The company will launch the Summit arthroscope in the first quarter of 2023 using a subscription pricing model.