AeroForm Tissue Expander, Smooth
K-Number: K191138 · 2019-07-11
Device Summary
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. The listed applicant is Airxpanders, Inc.. The 510(k) number is K191138.
When did AeroForm Tissue Expander, Smooth receive FDA 510(k) clearance?
AeroForm Tissue Expander, Smooth received FDA 510(k) clearance on 2019-07-11, under 510(k) number K191138.
Who is the listed applicant for AeroForm Tissue Expander, Smooth?
The FDA 510(k) record lists Airxpanders, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AeroForm Tissue Expander, Smooth?
The FDA product code for AeroForm Tissue Expander, Smooth is PQN.
Other records listing Airxpanders, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PQN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.