Guard Medical Obtains FDA’s 510(k) Clearance for More Sizes of Its Surgical Dressing

February 18, 2022

Guard Medical has received the FDA’s 510(k) clearance for the new 10- and 15-cm sizes of its negative pressure (NP) wound therapy dressing NPseal for surgical incisions.

NPseal features an integrated pump that maintains negative pressure after several pinches from the healthcare provider.

Negative pressure wound therapy has been shown to reduce surgical site infections in multiple studies, but it is in limited use due to the high cost and complexity of existing systems.

NPseal delivers the same type of therapy at a lower cost than the currently available, more complex devices, the Miami, Fla.-based company said.

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