Ethicon received FDA approval for the Megadyne Electrosurgical Generator K213696 on January 21, 2022.
The Megadyne™ Electrosurgical Generator K213696 is new iteration in the line of Ethicon Megadyne™ Electrosurgical Generators. It is intended to be used as a general-purpose electrosurgical generator for use in a wide variety of both open and laparoscopic procedures. It is a microprocessor controlled, isolated output, high frequency generator with the ability to facilitate both monopolar cutting and coagulation as well as bipolar coagulation through an accessory electrode. The electrosurgical generator requires an accessory electrode to deliver the radiofrequency energy to the target tissue.
When comparing this Megadyne™ Electrosurgical Generator to its predicate device K193145, there are three main differences as follows: maximum power output/setting of the monopolar mode has been decreased except for the GEM mode, the auto-bipolar option has been removed, and the single plate electrode accessories will not be compatible with this new design. The device includes a soft coagulation mode which provides coagulation at a slow rate with deep thermal penetration.
The device was tested against a comparable predicate device by measuring the thermal effect on tissue. Testing was performed at both default and maximum power settings with no significant difference in thermal effect.
The FDA has determined this device to be substantially equivalent to its predicate device, the Ethicon Megadyne™ Electrosurgical Generator K193145.
The device is approved to deliver radiofrequency current for cutting and coagulation needs in both open and laparoscopic surgical procedures.
