PQI · Class II · 21 CFR 878.4371

FDA Product Code PQI: Wound Retraction And Protection System

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.

Leading manufacturers include Prescient Surgical and Prescient Surgical, Inc..

2
Total
1
Cleared
297d
Avg days
2016
Since

FDA 510(k) Cleared Wound Retraction And Protection System Devices (Product Code PQI)

2 devices
1–2 of 2
Cleared Oct 25, 2017
CleanCision Wound Retraction and Protection System
K172132
Prescient Surgical, Inc.
General & Plastic Surgery · 103d
Not Cleared Dec 16, 2016
CleanCisionTM Wound Retraction and Protection System
DEN150038
Prescient Surgical
General & Plastic Surgery · 491d

About Product Code PQI - Regulatory Context