SurgiTools Pty Ltd, a Woodvale, Australia-based medical device manufacturer, has obtained 510(k) clearance from the US Food and Drug Administration to sell its Singh Colpotomizer System in the US with assistance from medical device regulatory consultancy Emergo Group. The Singh Colpotomizer System is designed for use in performing total laparoscopic hysterectomies, and provides enhanced visualization capabilities to surgeons in order to minimize injuries that can occur during laparoscopic procedures.
