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Surgipath

Country not established

Devices
12

What Surgipath makes

Surgipath manufactures laboratory reagents and processing aids for histopathology, including mounting media like ACRYTOL, decalcifiers such as DECALCIFIER II, and tissue processing solutions like MODIFIED EA 50. These products support tissue preparation for microscopic examination in clinical and research settings.

The company’s products are classified as Class I medical devices under FDA regulations and are authorised via the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

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

Catalogue12

Newest first, rows 1-12 of 12

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  • Ea 65 Ref K812086

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

  • 10% Neutral Buffered Formalin Concent Ref K812940

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

  • Ea 50 Ref K812087

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

  • Gill's Hematoxylin #3 Ref K810760

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

  • Gill's Hematoxylin #2 Ref K810759

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

  • Eosin Y Ref K811826

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

  • Gill's Hematoxylin #1 Ref K810758

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

  • Orange G-6 Ref K811825

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

  • Harris Hematoxylin Ref K810733

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

  • Acrytol, Mounting Medium Ref K810323

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

  • Decalcifier Ii Ref K810836

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

  • Modified Ea 50 Ref K820027

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Surgipath have in the registry?

The registry currently lists 12 devices for Surgipath. Devices recorded under merged duplicate company entries are counted once.

Which registries list Surgipath's devices?

Among its 12 most recently registered devices, Surgipath has devices listed in FDA 510(k) (12 devices).

What risk classes do Surgipath's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Surgipath's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Surgipath in the registry?

The most recently registered devices listed for Surgipath include EA 65, 10% NEUTRAL BUFFERED FORMALIN CONCENT, EA 50 and GILL'S HEMATOXYLIN #3.

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