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FDA 510(k)

IBS System

K-Number: K220517 · 2022-12-20

ApplicantInnobiosurg Co., Ltd.
Decision Date2022-12-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IBS 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 2022-12-20 under 510(k) number K220517. 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 IBS System?

IBS System is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Innobiosurg Co., Ltd.. The 510(k) number is K220517.

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

IBS System received FDA 510(k) clearance on 2022-12-20, under 510(k) number K220517.

Who is the listed applicant for IBS 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 IBS System?

The FDA product code for IBS 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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