SurgiTools, an Australia-based medical device manufacturer, has announced it has received 510(k) clearance from FDA to sell its Singh Colpotomizer System in the United States, according to a news release.
The Singh Colpotomizer System is designed for use in performing total laparoscopic hysterectomies. It is intended to provide improved visualization to surgeons in order to minimize patient injuries.
SurgiTools worked with medical device regulatory consultancy Emergo Group secure the 510(k) clearance.
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