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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 the device name listed in this FDA 510(k) record. The listed applicant is Airxpanders, Inc.. It received FDA 510(k) clearance on 2017-04-03 under 510(k) 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. The listed applicant is Airxpanders, Inc.. The 510(k) number is K170075.

When did AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) receive FDA 510(k) clearance?

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

Who is the listed applicant for AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)?

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 (v3.0), AeroForm Dosage Controller (v1.5)?

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

K191138AeroForm Tissue Expander, Smooth

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.

K191138AeroForm Tissue Expander, SmoothAirxpanders, Inc.

Official Source

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

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