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FDA 510(k)

Magicore Narrow System

K-Number: K220079 · 2022-12-14

Decision Date2022-12-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Magicore Narrow System is a medical device manufactured by Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under approval number K220079. 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 Narrow System?

Magicore Narrow System is a medical device that received FDA 510(k) clearance on 2022-12-14. It is manufactured by Innobiosurg Co., Ltd.. The 510(k) number is K220079.

When was Magicore Narrow System approved by the FDA?

Magicore Narrow System received FDA 510(k) clearance on 2022-12-14, under approval number K220079.

What company makes Magicore Narrow System?

Magicore Narrow System is manufactured by Innobiosurg Co., Ltd..

What is the FDA product code for Magicore Narrow System?

The FDA product code for Magicore Narrow System is DZE.

Related Clinical Trials

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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.