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Medtronic’s Sheathed Bipolar Sealer Granted 510(k) Clearance

September 11, 2018

The FDA handed 510(k) clearance to Minneapolis devicemaker Medtronic’s Aquamantys sheathed bipolar sealer, a device used for hemostatic sealing during spinal cases.

The device enables surgeons to stop bleeding from cut muscle and epidural veins using a combination of radiofrequency energy and saline in order to reduce blood loss and increase visualization during spinal procedures.

The device’s ability to reduce blood loss has been linked to faster surgery times and reduced rates of blood transfusions.

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