FDA 510(k)

Trexo Theo

K-Number: K254198 · 2026-09-02

Decision Date2026-09-02

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Trexo Theo is the device name listed in this FDA 510(k) record. The listed applicant is Trexo Robotics, Inc.. It received FDA 510(k) clearance on 2026-09-02 under 510(k) number K254198. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trexo Theo?

Trexo Theo is a medical device that received FDA 510(k) clearance on 2026-09-02. The listed applicant is Trexo Robotics, Inc.. The 510(k) number is K254198.

When did Trexo Theo receive FDA 510(k) clearance?

Trexo Theo received FDA 510(k) clearance on 2026-09-02, under 510(k) number K254198.

Who is the listed applicant for Trexo Theo?

The FDA 510(k) record lists Trexo Robotics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trexo Theo?

The FDA product code for Trexo Theo is PHL.

Related Devices (Code: PHL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.