AeroForm Tissue Expander, Smooth
K-Number: K191138 · 2019-07-11
ApplicantAirxpanders, Inc.
Decision Date2019-07-11
Product CodePQN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AeroForm Tissue Expander, Smooth is a medical device manufactured by Airxpanders, Inc.. It received FDA 510(k) clearance on 2019-07-11 under approval number K191138. 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, Smooth?
AeroForm Tissue Expander, Smooth is a medical device that received FDA 510(k) clearance on 2019-07-11. It is manufactured by Airxpanders, Inc.. The 510(k) number is K191138.
When was AeroForm Tissue Expander, Smooth approved by the FDA?
AeroForm Tissue Expander, Smooth received FDA 510(k) clearance on 2019-07-11, under approval number K191138.
What company makes AeroForm Tissue Expander, Smooth?
AeroForm Tissue Expander, Smooth is manufactured by Airxpanders, Inc..
What is the FDA product code for AeroForm Tissue Expander, Smooth?
The FDA product code for AeroForm Tissue Expander, Smooth is PQN.
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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.