FDA Product Code OMP: Negative Pressure Wound Therapy Powered Suction Pump

FDA product code OMP covers powered suction pumps for negative pressure wound therapy.

These devices apply controlled sub-atmospheric pressure to a wound bed via a foam or gauze dressing and sealed film, promoting granulation tissue formation, reducing edema, and removing wound exudate. NPWT is used in the management of complex wounds, surgical incisions, and pressure injuries.

OMP devices are Class II medical devices, regulated under 21 CFR 878.4780 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Genadyne Biotechnologies, Inc., Smith & Nephew Medical, Ltd. and Smith & Nephew Medical Limited.