Product code PQN— General, Plastic Surgery

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)

Classification name: Carbon Dioxide Gas Controlled Tissue Expander
Device class: Class 2
Regulation: 21 CFR 878.3510
Advisory panel: General, Plastic Surgery
Total cleared: 3
First cleared: 2016-12-21
Most recent: 2019-07-11

FDA classification definition

“A carbon dioxide gas controlled tissue expander is intended for tissue expansion.”
— U.S. Food and Drug Administration, device classification record for product code PQN under 21 CFR 878.3510, via openFDA

Market context for product code PQN

FDA has cleared 3 devices under product code PQN between 2016 and 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20191 clearance
20171 clearance
20161 clearance

Top applicants under product code PQN

Airxpanders, Inc.3 clearances

Recent clearances under product code PQN

Data sourced from openFDA. This site is unofficial and independent of the FDA.