Acclarent Gains 510(k) Clearance for TruDi Shaver Blade

The FDA has granted 510(k) clearance to Johnson & Johnson subsidiary Acclarent for its TruDi Shaver Blade device.

The single-use electromagnetically navigated blade is for use with Bien-Air Surgery’s S120 shaver for removal of soft and hard tissue or bone in a range of surgical procedures, including ear, nose and throat, maxillofacial surgery, head and neck and skull base surgery.

The device features a distal tip sensor that displays the blade’s position on the company’s TruDi navigation system.

Acclarent is focused on developing novel technologies for safe and effective treatments in ear, nose and throat areas.