Siemens Radiotom 904 & 904E Electrosurgery Unit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K912070 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Siemens Radiotom 904 & 904E Electrosurgery Unit used for?

  The Siemens Radiotom 904 & 904E Electrosurgery Unit is designed for surgical procedures requiring precise cutting and coagulation of tissue. It delivers radiofrequency energy to achieve hemostasis and tissue dissection in a controlled manner.

• What is the regulatory status of the Radiotom 904 & 904E Electrosurgery Unit?

  The unit received FDA 510(k) clearance (K912070) under a Traditional clearance type on April 23, 1992. It is classified with product code GEI and was determined to be substantially equivalent to a predicate device.

• Is the Radiotom 904 & 904E Electrosurgery Unit reusable or single-use?

  The device data does not specify whether the Radiotom 904 & 904E Electrosurgery Unit is designed for single-use or multiple uses. This information would be detailed in the manufacturer's instructions for use provided with the device.

• What sizes or models are available for the Radiotom 904 & 904E Electrosurgery Unit?

  The device data mentions two models: the Radiotom 904 and the Radiotom 904E. No additional size specifications or model variations are provided in the available information.