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FDA 510(k)

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)

K-Number: K170075 · 2017-04-03

ApplicantAirxpanders, Inc.
Decision Date2017-04-03
Product CodePQN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) is a medical device manufactured by Airxpanders, Inc.. It received FDA 510(k) clearance on 2017-04-03 under approval number K170075. The device is classified under product code PQN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)?

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) is a medical device that received FDA 510(k) clearance on 2017-04-03. It is manufactured by Airxpanders, Inc.. The 510(k) number is K170075.

When was AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) approved by the FDA?

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) received FDA 510(k) clearance on 2017-04-03, under approval number K170075.

What company makes AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)?

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) is manufactured by Airxpanders, Inc..

What is the FDA product code for AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)?

The FDA product code for AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) is PQN.

Related Clinical Trials

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Other Devices by Airxpanders, Inc.

DEN150055AeroForm Tissue Expander System K191138AeroForm Tissue Expander, Smooth

Related Devices (Code: PQN)

DEN150055AeroForm Tissue Expander SystemAirxpanders, Inc. K191138AeroForm Tissue Expander, SmoothAirxpanders, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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