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FDA 510(k)

Electrosurgical accessory

K-Number: K183126 · 2019-05-08

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2019-05-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrosurgical accessory is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2019-05-08 under 510(k) number K183126. 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 accessory?

Electrosurgical accessory is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K183126.

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

Electrosurgical accessory received FDA 510(k) clearance on 2019-05-08, under 510(k) number K183126.

Who is the listed applicant for Electrosurgical accessory?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical accessory?

The FDA product code for Electrosurgical accessory is GEI.

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Official Source

View on FDA Database →

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

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