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Acuvu, Inc.

United StatesFDA applicant, unverified

Devices
2

What Acuvu, Inc. makes

Acuvu, Inc. manufactures the HTx Disposable Hysteroscope System and the GDT-1000 System, both of which are medical devices.

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

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • HTx Disposable Hysteroscope System Ref K211227

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • GDT-1000 System Ref K180096

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

Frequently asked questions

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

The registry currently lists 2 devices for Acuvu, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Acuvu, Inc.'s devices?

Among its 2 most recently registered devices, Acuvu, Inc. has devices listed in FDA 510(k) (2 devices).

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

Among its 2 most recently registered devices, the classes recorded for Acuvu, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Acuvu, Inc. include HTx Disposable Hysteroscope System and GDT-1000 System.

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