Carbon Dioxide Gas Controlled Tissue Expander
The Carbon Dioxide Gas Controlled Tissue Expander is an implantable device used for tissue expansion prior to reconstructive surgery, using carbon dioxide gas as the inflation medium rather than saline, allowing controlled expansion via an external control system. It is classified as FDA Class 2 under 21 CFR 878.3510 in the General and Plastic Surgery specialty, requiring 510(k) premarket notification. Product code PQN; flagged as an implant; not life-sustaining.
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Basic Information
- Product Code
- PQN
- Device Class
- FDA class 2
- Regulation Number
- 878.3510
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191138 | AeroForm Tissue Expander, Smooth | Jul 11, 2019 | Substantially Equivalent | Airxpanders, Inc. |
| K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | Apr 03, 2017 | Substantially Equivalent | Airxpanders, Inc. |
| DEN150055 | AeroForm Tissue Expander System | Dec 21, 2016 | Unknown | Airxpanders, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.