Decision Date2025-06-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HybridAPC probe is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-06-20 under approval number K243120. 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 HybridAPC probe?
HybridAPC probe is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K243120.
When was HybridAPC probe approved by the FDA?
HybridAPC probe received FDA 510(k) clearance on 2025-06-20, under approval number K243120.
What company makes HybridAPC probe?
HybridAPC probe is manufactured by Erbe Elektromedizin GmbH.
What is the FDA product code for HybridAPC probe?
The FDA product code for HybridAPC probe 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.