510(k) K191138
K191138 is an FDA 510(k) premarket notification submitted by Airxpanders, Inc. for the device "AeroForm Tissue Expander, Smooth". The FDA issued a decision of Substantially Equivalent on Jul 11, 2019. 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
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 2019
- Date Received
- Apr 30, 2019
- Clearance Type
- Special
- 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.