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.
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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.