PQI

Wound Retraction And Protection System

Product code

PQI

Device name

Wound Retraction And Protection System

Device class

Class 2

21 CFR

21 CFR 878.4371

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).