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Exitec, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
4

What Exitec, Inc. makes

Exitec, Inc. manufactures diagnostic imaging devices, including the DIA-SPEC, PRO-SCOPE, DIA SCOPE, and PRO-SPEC. These products appear to be specialized scopes and diagnostic tools designed for internal medical examinations, likely used in urology or similar specialties.

The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices. These devices are listed in the FDA’s 510(k) registry, indicating compliance with U.S. regulatory requirements. The manufacturer is based in the United States.

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

Catalogue4

Newest first, rows 1-4 of 4

  • Dia-Spec Ref K822086

    Class II
    Active 510(k) 510(k) II

  • Pro-Scope Ref K822085

    Class II
    Active 510(k) 510(k) II

  • Dia Scope Ref K822087

    Class II
    Active 510(k) 510(k) II

  • Pro-Spec Ref K822084

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

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

The registry currently lists 4 devices for Exitec, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Exitec, Inc.'s devices?

Among its 4 most recently registered devices, Exitec, Inc. has devices listed in FDA 510(k) (4 devices).

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

Among its 4 most recently registered devices, the classes recorded for Exitec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Exitec, Inc. include DIA-SPEC, PRO-SCOPE, DIA SCOPE and PRO-SPEC.

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