www.fdanews.com/articles/203734-asensus-surgical-gets-fda-510k-clearance-for-articulating-instruments
Asensus Surgical Gets FDA 510(k) Clearance for Articulating Instruments
July 29, 2021
Asensus Surgical has received 510(k) clearance from the FDA for its 5-millimeter diameter articulating instruments.
The devices, which previously earned CE mark certification, work on the company’s Senhance Surgical System, a digital laparoscopic platform that uses augmented intelligence and machine learning.
The articulating instruments “offer better access to difficult-to-reach areas of the anatomy” by providing additional degrees of freedom, the company said.