Product code OKO

Device name

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4683

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

Source

FDA openFDA device classification dataset