Magicore System
K-Number: K201981 · 2020-08-27
ApplicantInnobiosurg Co., Ltd.
Decision Date2020-08-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Magicore System is a medical device manufactured by Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2020-08-27 under approval number K201981. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Magicore System?
Magicore System is a medical device that received FDA 510(k) clearance on 2020-08-27. It is manufactured by Innobiosurg Co., Ltd.. The 510(k) number is K201981.
When was Magicore System approved by the FDA?
Magicore System received FDA 510(k) clearance on 2020-08-27, under approval number K201981.
What company makes Magicore System?
Magicore System is manufactured by Innobiosurg Co., Ltd..
What is the FDA product code for Magicore System?
The FDA product code for Magicore System is DZE.
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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.