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FDA 510(k)

ESU-1 Electrosurgical Generator

K-Number: K162656 · 2016-11-10

ApplicantTva Medical, Inc.
Decision Date2016-11-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESU-1 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Tva Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) 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. The listed applicant is Tva Medical, Inc.. The 510(k) number is K162656.

When did ESU-1 Electrosurgical Generator receive FDA 510(k) clearance?

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

Who is the listed applicant for ESU-1 Electrosurgical Generator?

The FDA 510(k) record lists Tva Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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