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Endotronics, Inc.

United StatesFDA applicant, unverified

Devices
3

What Endotronics, Inc. makes

Endotronics, Inc. manufactures cell culture equipment, including systems like the ACUSYST-JR, ACUSYST-P, and ACUSYST-P/3X, designed for controlled environmental conditions in laboratory settings.

These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

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

Catalogue3

Newest first, rows 1-3 of 3

  • Acusyst-Jr Ref K872086

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Acusyst-P (Cell Culture Equipment) Ref K864334

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Acusyst-P/3X Ref K875151

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

Frequently asked questions

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

The registry currently lists 3 devices for Endotronics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Endotronics, Inc.'s devices?

Among its 3 most recently registered devices, Endotronics, Inc. has devices listed in FDA 510(k) (3 devices).

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

Among its 3 most recently registered devices, the classes recorded for Endotronics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Endotronics, Inc. include ACUSYST-JR, ACUSYST-P (CELL CULTURE EQUIPMENT) and ACUSYST-P/3X.

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