Class Class II

The ETHICON™ Total Energy System (K243067)

K243067 2025-01-17 Traditional
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Description

The ETHICON™ Total Energy System by Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company), an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243067
Clearance Date2025-01-17
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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Predicate lineage for K243067

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. The ETHICON™ Total Energy System (K243067) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm lengt...Ethicon Endo-Surgery, LLC2020
K193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMegadyne Medical Products, Inc.2020

Trace the full predicate network for K243067

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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