PQN · Class II · 21 CFR 878.3510

FDA Product Code PQN: Carbon Dioxide Gas Controlled Tissue Expander

A Carbon Dioxide Gas Controlled Tissue Expander Is Intended For Tissue Expansion.

Leading manufacturers include Airxpanders, Inc..

3
Total
2
Cleared
179d
Avg days
2016
Since

FDA 510(k) Cleared Carbon Dioxide Gas Controlled Tissue Expander Devices (Product Code PQN)

3 devices
1–3 of 3
Cleared Jul 11, 2019
AeroForm Tissue Expander, Smooth
K191138
Airxpanders, Inc.
General & Plastic Surgery · 72d
Cleared Apr 03, 2017
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
K170075
Airxpanders, Inc.
General & Plastic Surgery · 84d
Not Cleared Dec 21, 2016
AeroForm Tissue Expander System
DEN150055
Airxpanders, Inc.
General & Plastic Surgery · 380d

About Product Code PQN - Regulatory Context