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O.R. Concepts, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
34

What O.R. Concepts, Inc. makes

O.R. Concepts, Inc. manufactures surgical accessories and electrosurgical tools, including irrigating and suction kits, electrosurgical probes and handles, instrument organizers, drapes, and protective barriers like eye barriers and reflective blankets. Their products also include specialized accessories such as a microscope column drape, cable harnesses, and a device for holding cannulas.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products cleared via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

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

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Frequently asked questions

How many devices does O.R. Concepts, Inc. have in the registry?

The registry currently lists 34 devices for O.R. Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list O.R. Concepts, Inc.'s devices?

Among its 34 most recently registered devices, O.R. Concepts, Inc. has devices listed in FDA 510(k) (34 devices).

What risk classes do O.R. Concepts, Inc.'s devices fall under?

Among its 34 most recently registered devices, the classes recorded for O.R. Concepts, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from O.R. Concepts, Inc. in the registry?

The most recently registered devices listed for O.R. Concepts, Inc. include O.R. CONCEPTS' IRRIGATING KITTNER, FLOWGUN ELECTROCAUTERY PROBES, FLOWGUN ELECTROCAUTERY PROBE HANDLE and O.R. CONCEPTS ELECTROSURGICAL PROBES.

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