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FDA 510(k)

The ETHICON™ Total Energy System

K-Number: K243067 · 2025-01-17

ApplicantEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)
Decision Date2025-01-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The ETHICON™ Total Energy System is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company). It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243067. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The ETHICON™ Total Energy System?

The ETHICON™ Total Energy System is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company). The 510(k) number is K243067.

When did The ETHICON™ Total Energy System receive FDA 510(k) clearance?

The ETHICON™ Total Energy System received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243067.

Who is the listed applicant for The ETHICON™ Total Energy System?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The ETHICON™ Total Energy System?

The FDA product code for The ETHICON™ Total Energy System is GEI.

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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.

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