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Urothealth System, Inc.

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Devices
1

What Urothealth System, Inc. makes

Urothealth System, Inc. manufactures percutaneous breast biopsy (PBB) devices, which are medical instruments used for obtaining tissue samples from the breast through the skin.

The company's devices are classified as Class II and are listed in the FDA 510(k) registry. Urothealth System, Inc. is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

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Frequently asked questions

How many devices does Urothealth System, Inc. have in the registry?

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

Which registries list Urothealth System, Inc.'s devices?

Among its 1 most recently registered device, Urothealth System, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Urothealth System, Inc.'s devices fall under?

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

What are the newest devices from Urothealth System, Inc. in the registry?

The most recently registered devices listed for Urothealth System, Inc. include PERCUTANEOUS BREAST BIOPSY (PBB).

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