On April 9, Peleton Surgical announced via a press release that it has received FDA clearance (K240071) to market its single-use surgical power driver.
The press release states that “The costs and patient risk associated with re-usable surgical drivers represent a challenge for healthcare facilities, and Peleton Surgical's solution will improve patient safety, enable better economics, and ease workflows for surgeons and staff.”
The drivers and accessories, according to the release, are delivered to the surgery centers and hospitals fully charged, sterile, and ready to use in the operating room.
The press release adds that “The FDA clearance is the first-ever for a single-use surgical power driver, and FDA created a new product category to pursue the evaluation and clearance for the device. Peleton Surgical wanted FDA to undertake a thorough review of functional and safety data associated with the use of a surgical power driver, to create standards in an area where improper cleaning and frequent battery charges can result in patient risk and operational inefficiencies. As a result, Peleton went through very extensive testing prior to FDA clearance being granted. Testing involved the surgical driver, its attachments, and its accessories, all from leading surgical power driver manufacturers.”
PRWeb has the press release.
