510(k) K170075
K170075 is an FDA 510(k) premarket notification submitted by Airxpanders, Inc. for the device "AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)". The FDA issued a decision of Substantially Equivalent on Apr 3, 2017. 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
- Apr 3, 2017
- Date Received
- Jan 9, 2017
- Clearance Type
- Traditional
- 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.