The ETHICON Total Energy System
K-Number: K243067 · 2025-01-17
Decision Date2025-01-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
The ETHICON Total Energy System is a medical device manufactured by Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company). It received FDA 510(k) clearance on 2025-01-17 under approval 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. It is manufactured by Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company). The 510(k) number is K243067.
When was The ETHICON Total Energy System approved by the FDA?
The ETHICON Total Energy System received FDA 510(k) clearance on 2025-01-17, under approval number K243067.
What company makes The ETHICON Total Energy System?
The ETHICON Total Energy System is manufactured by Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company).
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.