510(k) DEN150055
DEN150055 is an FDA 510(k) premarket notification submitted by Airxpanders, Inc. for the device "AeroForm Tissue Expander System". The FDA issued a decision of De Novo granted on Dec 21, 2016. The device falls under product code PQN (Carbon Dioxide Gas Controlled Tissue Expander), a Class II device regulated under 21 CFR 878.3510. Airxpanders, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Dec 21, 2016
- Date Received
- Dec 7, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carbon Dioxide Gas Controlled Tissue Expander
- Device Class
- Class II
- Regulation Number
- 878.3510
- Review Panel
- SU
- Submission Type
- 510(k)
A carbon dioxide gas controlled tissue expander is intended for tissue expansion.