Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
by Megadyne Medical Products, Inc.
510(k) K193145
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK193145 | Date24 Mar 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is a microprocessor-controlled, isolated-output, high-frequency generator designed for bipolar coagulation in surgical procedures. It delivers controlled electrosurgical energy through a footswitch interface, enabling precise tissue management during operations. This device is classified under the product code GEI (Electrosurgical Units, General Purpose) and is intended for use in various surgical settings requiring bipolar energy applications. Its design supports integration with compatible electrosurgical generators for enhanced procedural control.
The device is supplied as a reusable accessory, intended for use in hospitals, surgical centers, and biomedical departments. It is not sterile and must be cleaned and maintained according to manufacturer guidelines between uses. The footswitch operates within the parameters of the connected generator, ensuring compatibility with the MEGEN1 electrosurgical generator system. Regulatory authorizations include FDA 510(k) clearance under the Traditional pathway, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). No specific MRI safety information is provided in the specifications.
Other devices from Megadyne Medical Products, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is this footswitch designed for single-use or can it be reused in multiple procedures?
This footswitch is explicitly marked as a reusable accessory, intended for use in hospitals, surgical centers, and biomedical departments. It must be cleaned and maintained according to the manufacturer’s guidelines between uses, as it is not sterile out-of-the-box.
What electrosurgical generator systems is this footswitch compatible with, and how does it integrate with them?
The Ethicon Megadyne Bipolar Footswitch is designed to operate within the parameters of the MEGEN1 electrosurgical generator system. It connects as a compatible accessory, enabling precise bipolar coagulation control during surgical procedures when paired with that specific generator.
How is this device regulated, and what pathways were followed for its approval?
The device holds FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). The submission was reviewed by the Surgical Devices (SU) Advisory Committee and filed under product code GEI (Electrosurgical Units, General Purpose).
Does this footswitch come pre-sterilized, or does it require sterilization before first use?
The footswitch is not sterile as supplied. It is intended for reusable use in clinical settings, meaning it must be cleaned and maintained per manufacturer instructions before each procedure. Sterilization is not implied or required for initial use.