FDA product code PQN

Carbon Dioxide Gas Controlled Tissue Expander

General, Plastic Surgery·Class 2·21 CFR 878.3510·Implantable
US regulatory classifications
US Product Code (FDA)
PQN
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.3510
View CFR Regulation →
Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

A carbon dioxide gas controlled tissue expander is intended for tissue expansion.

Search keywords
About this record

Carbon Dioxide Gas Controlled Tissue Expander is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.