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Home » Intuitive Surgical scores FDA clearance for gall bladder surgery | Regulatory Roundup

Intuitive Surgical scores FDA clearance for gall bladder surgery | Regulatory Roundup

December 13, 2011 By MassDevice staff

Intuitive Surgical

Intuitive Surgical (NSDQ:ISRG) won 510(k) clearance from the FDA for its da Vinci surgical robot to be used in laparoscopic cholecystectomy – or gall bladder surgery.

The clearance for Sunnyvale, Calif.-based Intuitive covers single-site instrumentation for the da Vinci Si model, which will allow surgeons with the device to perform single-incision cholecystectomies, according to a press release.

“We plan to immediately initiate a controlled roll-out of these products in the US, while continuing our roll-out in Europe,” CEO Gary Guthart said in prepared remarks. “As we learn more about our customers’ needs within single-incision surgery, we anticipate future submissions to the US FDA and other global regulatory agencies related to expansion of the cleared indications for use, as well as additional Single-Site instruments.”

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Regulatory Roundup

Soteira lands 510(k) for kyphoplasty device
Soteira Inc. won 510(k) clearance for its Shield kyphoplasty system, fueled by a series of laboratory, animal, cadaver and clinical studies. Read more

EnteroMedics lands
EnteroMedics Inc. (NSDQ:ETRM) won approval from the Australian Therapeutic Goods Administration for “the critical active implantable medical device components” of its Maestro weight loss implant. Read more

Filed Under: 510(k), News Well, Spine, Surgical Robotics Tagged With: Bariatrics, EnteroMedics Inc., Exports, Intuitive Surgical, Soteira Inc.

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