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Medical Devices / Regulatory Affairs / Submissions and Approvals

TauTona Tissue Injector Wins 510(k) Clearance

Nov. 22, 2013

The FDA Wednesday granted TauTona 510(k) clearance for its battery-powered, single use TauTona Tissue Injector (TTI) fat-grafting device for use in aesthetic and reconstructive surgeries. The Menlo Park, Calif., company plans to make the device available to surgeons, hospitals and outpatient surgery centers by mid-2014.

The TTI, which removes fat and connective tissue from one part of the body and injects it into another, is automated to allow physicians to inject the tissue at an even and controlled rate while keeping track of pressure and flow rates that might otherwise damage healthy adipose tissue. This should not only improve physicians’ accuracy and efficiency but also lower procedure costs and reduce the time to reinjection.

The automated flow feature also guards against clogging, which can occur when tissue is manually injected using a syringe, said TauTona spokesman Geoffrey Gurtner.

TauTona was granted a U.S. patent on its ITT technology on Nov. 14. Several other patents are pending on the device in the U.S. and abroad, the company said.

The ITT is TauTona’s second product. The Menlo Park, Calif., company also developed a surgical marker technology, which it sold to Novadaq Technologies earlier this year. The company’s pipeline includes several products for reconstructive surgery, wound healing and aesthetic procedures, Gurtner said. — Lena Freund

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