FDA product code PQN: Carbon Dioxide Gas Controlled Tissue Expander
PQN is the FDA product code for carbon dioxide gas controlled tissue expander. It is a Class II device, regulated under 21 CFR 878.3510 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under PQN. The average 510(k) review took 78 days (median 78). 1 De Novo request was granted under it.
Definition
A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
Classification
| Field | Value |
|---|---|
| Device name | Carbon Dioxide Gas Controlled Tissue Expander |
| Device class | Class II |
| Regulation | 21 CFR 878.3510 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PQN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 84 |
| 2019 | 1 | 72 |
Compare with all 510(k) review times · Search every PQN clearance
Top PQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Airxpanders, Inc. | 2 | 2019-07-11 |
Most recent PQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191138 | Airxpanders, Inc. | AeroForm Tissue Expander, Smooth | 2019-07-11 | 72 |
| K170075 | Airxpanders, Inc. | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | 2017-04-03 | 84 |
Recalls for PQN devices
openFDA lists no recalls for product code PQN.
Frequently asked questions
What is FDA product code PQN?
PQN is the FDA product code for carbon dioxide gas controlled tissue expander. It is a Class II device, regulated under 21 CFR 878.3510 and reviewed by the General and Plastic Surgery panel.
What device class is PQN?
Class II, regulation 21 CFR 878.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQN?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most PQN clearances?
Airxpanders, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PQN
- Run a recall and safety report across every PQN manufacturer
- Watch product code PQN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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