Decision Date2023-11-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HYBRIDknife® flex is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2023-11-29 under approval number K232033. 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 HYBRIDknife® flex?
HYBRIDknife® flex is a medical device that received FDA 510(k) clearance on 2023-11-29. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K232033.
When was HYBRIDknife® flex approved by the FDA?
HYBRIDknife® flex received FDA 510(k) clearance on 2023-11-29, under approval number K232033.
What company makes HYBRIDknife® flex?
HYBRIDknife® flex is manufactured by Erbe Elektromedizin GmbH.
What is the FDA product code for HYBRIDknife® flex?
The FDA product code for HYBRIDknife® flex 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.