510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQNClass II

Carbon Dioxide Gas Controlled Tissue Expander

21 CFR 878.3510 / General, Plastic Surgery
FDA source (opens on fda.gov)

PQN is the FDA product code for Carbon Dioxide Gas Controlled Tissue Expander, a class II device type, regulated under 21 CFR 878.3510. FDA's definition for this code reads: "A carbon dioxide gas controlled tissue expander is intended for tissue expansion". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PQN
Device name
Carbon Dioxide Gas Controlled Tissue Expander
FDA definition
A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
Regulation
21 CFR 878.3510
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PQN

By decision year
3 clearances under product code PQN with a decision year between 2016 and 2019, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PQN by decision year
YearClearances
20161
20171
20191

Applicants with the most clearances

Product code PQN
Applicants holding the most 510(k) clearances under product code PQN
ApplicantClearances
Airxpanders, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code