ControlSeal Electrode (ELSB)
K-Number: K223605 · 2022-12-30
ApplicantCoapt
Decision Date2022-12-30
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ControlSeal Electrode (ELSB) is a medical device manufactured by Coapt. It received FDA 510(k) clearance on 2022-12-30 under approval number K223605. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ControlSeal Electrode (ELSB)?
ControlSeal Electrode (ELSB) is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Coapt. The 510(k) number is K223605.
When was ControlSeal Electrode (ELSB) approved by the FDA?
ControlSeal Electrode (ELSB) received FDA 510(k) clearance on 2022-12-30, under approval number K223605.
What company makes ControlSeal Electrode (ELSB)?
ControlSeal Electrode (ELSB) is manufactured by Coapt.
What is the FDA product code for ControlSeal Electrode (ELSB)?
The FDA product code for ControlSeal Electrode (ELSB) is GXY.
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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.