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FDA 510(k)

LAP-iX

K-Number: K200639 · 2021-09-29

ApplicantSejong Medical Co., Ltd.
Decision Date2021-09-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAP-iX is a medical device manufactured by Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-09-29 under approval number K200639. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAP-iX?

LAP-iX is a medical device that received FDA 510(k) clearance on 2021-09-29. It is manufactured by Sejong Medical Co., Ltd.. The 510(k) number is K200639.

When was LAP-iX approved by the FDA?

LAP-iX received FDA 510(k) clearance on 2021-09-29, under approval number K200639.

What company makes LAP-iX?

LAP-iX is manufactured by Sejong Medical Co., Ltd..

What is the FDA product code for LAP-iX?

The FDA product code for LAP-iX is GEI.

Other Devices by Sejong Medical Co., Ltd.

K173111LAP-iX Suction Irrigation K173112LAP-iX K171726LapBag K171741Laport K173108Smoklean K200638LAP-iX Suction Irrigation

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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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