Airxpanders, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Airxpanders, Inc. makes
Airxpanders, Inc. manufactures remotely-controlled tissue expanders and their corresponding remote controls, designed for gradual tissue expansion in medical procedures. The portfolio includes expanders with varying surface textures, such as smooth variants, as well as integrated systems combining the expander with a dosage controller for precise adjustments. These devices are intended for use in procedures requiring controlled tissue growth, such as breast reconstruction.
The company’s products are classified as Class II medical devices under regulatory frameworks, with authorisation obtained through FDA 510(k) and Unique Device Identifier (UDI) listings. These devices are intended for distribution in the United States, where the manufacturer is based.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
AeroForm Tissue Expander, Smooth Ref K191138
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
AeroForm Tissue Expander System Ref DEN150055
Regimes: De Novo Registry: De Novo
Company details
- DUNS number
- 860020127
- [email protected]
- Phone
- +1(877)349-2479
Frequently asked questions
How many devices does Airxpanders, Inc. have in the registry?
The registry currently lists 7 devices for Airxpanders, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Airxpanders, Inc.'s devices?
Among its 7 most recently registered devices, Airxpanders, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Airxpanders, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Airxpanders, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Airxpanders, Inc. in the registry?
The most recently registered devices listed for Airxpanders, Inc. include AeroForm® Tissue Expander 800cc Large, AeroForm® Tissue Expander 400cc Small, AeroForm® Dosage Controller V1.5 and AeroForm® Tissue Expander 600cc Medium.