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Bioana Surgical Instruments, Inc.

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Devices
1

What Bioana Surgical Instruments, Inc. makes

Bioana Surgical Instruments, Inc. manufactures the AIRE-CUF tracheostomy tube, a medical device designed for airway management in patients requiring tracheostomy procedures.

The AIRE-CUF tracheostomy tube is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Aire-Cuf Tracheostomy Tube Ref K812163

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Bioana Surgical Instruments, Inc. have in the registry?

The registry currently lists 1 device for Bioana Surgical Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioana Surgical Instruments, Inc.'s devices?

Among its 1 most recently registered device, Bioana Surgical Instruments, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Bioana Surgical Instruments, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Bioana Surgical Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bioana Surgical Instruments, Inc. in the registry?

The most recently registered devices listed for Bioana Surgical Instruments, Inc. include AIRE-CUF TRACHEOSTOMY TUBE.

Generated automatically from registry data and not verified by a human reviewer.