Product code PQI

Device name

Wound Retraction And Protection System

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4371

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

Source

FDA openFDA device classification dataset