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FDA 510(k)

Electrosurgical Generator

K-Number: K183564 · 2019-06-13

ApplicantFulwell, LLC
Decision Date2019-06-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Fulwell, LLC. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K183564. 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 Electrosurgical Generator?

Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Fulwell, LLC. The 510(k) number is K183564.

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

Electrosurgical Generator received FDA 510(k) clearance on 2019-06-13, under 510(k) number K183564.

Who is the listed applicant for Electrosurgical Generator?

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

What is the FDA product code for Electrosurgical Generator?

The FDA product code for Electrosurgical Generator is GEI.

Other records listing Fulwell, LLC as applicant

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.

K200931RF Surgical Generator

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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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