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FDA 510(k)

Electrosurgical accessory

K-Number: K183126 · 2019-05-08

Decision Date2019-05-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrosurgical accessory is a medical device manufactured by New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2019-05-08 under approval 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. It is manufactured by New Deantronics Taiwan , Ltd.. The 510(k) number is K183126.

When was Electrosurgical accessory approved by the FDA?

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

What company makes Electrosurgical accessory?

Electrosurgical accessory is manufactured by New Deantronics Taiwan , Ltd..

What is the FDA product code for Electrosurgical accessory?

The FDA product code for Electrosurgical accessory is GEI.

Other Devices by New Deantronics Taiwan , Ltd.

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Related Devices (Code: GEI)

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.