FDA 510(k)

LAP-iX Suction Irrigation

K-Number: K200638 · 2020-04-03

Decision Date2020-04-03

Product CodeHET

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LAP-iX Suction Irrigation is a medical device manufactured by Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-04-03 under approval number K200638. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAP-iX Suction Irrigation?

LAP-iX Suction Irrigation is a medical device that received FDA 510(k) clearance on 2020-04-03. It is manufactured by Sejong Medical Co., Ltd.. The 510(k) number is K200638.

When was LAP-iX Suction Irrigation approved by the FDA?

LAP-iX Suction Irrigation received FDA 510(k) clearance on 2020-04-03, under approval number K200638.

What company makes LAP-iX Suction Irrigation?

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

What is the FDA product code for LAP-iX Suction Irrigation?

The FDA product code for LAP-iX Suction Irrigation is HET.

Other Devices by Sejong Medical Co., Ltd.

K173111LAP-iX Suction Irrigation K173112LAP-iX K171726LapBag K171741Laport K173108Smoklean K200639LAP-iX

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Related Devices (Code: HET)

K173111LAP-iX Suction IrrigationSejong Medical Co., Ltd. K163320LAP-Pump PP110W.O.M. World of Medicine GmbH K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation K190190WV1 Endoscope270surgical , Ltd. K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.