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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2020-08-27 under 510(k) 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. The listed applicant is Innobiosurg Co., Ltd.. The 510(k) number is K201981.

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

Magicore System received FDA 510(k) clearance on 2020-08-27, under 510(k) number K201981.

Who is the listed applicant for Magicore 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 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.

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