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FDA 510(k)

Magicore Narrow System

K-Number: K220079 · 2022-12-14

ApplicantInnobiosurg Co., Ltd.
Decision Date2022-12-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Magicore Narrow System is the device name listed in this FDA 510(k) record. The listed applicant is Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under 510(k) 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. The listed applicant is Innobiosurg Co., Ltd.. The 510(k) number is K220079.

When did Magicore Narrow System receive FDA 510(k) clearance?

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

Who is the listed applicant for Magicore Narrow System?

The FDA 510(k) record lists Innobiosurg Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magicore Narrow System?

The FDA product code for Magicore Narrow System is DZE.

Other records listing Innobiosurg Co., Ltd. as applicant

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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.

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