FDA 510(k)

ESU-1 Electrosurgical Generator

K-Number: K162656 · 2016-11-10

Decision Date2016-11-10

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ESU-1 Electrosurgical Generator is a medical device manufactured by Tva Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under approval number K162656. 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 ESU-1 Electrosurgical Generator?

ESU-1 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Tva Medical, Inc.. The 510(k) number is K162656.

When was ESU-1 Electrosurgical Generator approved by the FDA?

ESU-1 Electrosurgical Generator received FDA 510(k) clearance on 2016-11-10, under approval number K162656.

What company makes ESU-1 Electrosurgical Generator?

ESU-1 Electrosurgical Generator is manufactured by Tva Medical, Inc..

What is the FDA product code for ESU-1 Electrosurgical Generator?

The FDA product code for ESU-1 Electrosurgical Generator is GEI.

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Official Source

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