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FDA 510(k)

LAP-iX Suction Irrigation

K-Number: K200638 · 2020-04-03

ApplicantSejong Medical Co., Ltd.
Decision Date2020-04-03
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAP-iX Suction Irrigation is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) 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. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K200638.

When did LAP-iX Suction Irrigation receive FDA 510(k) clearance?

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

Who is the listed applicant for LAP-iX Suction Irrigation?

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

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

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

Other records listing Sejong Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253165LAP-iX2NK252985LaportK200639LAP-iXK173108SmokleanK173111LAP-iX Suction IrrigationK173112LAP-iX

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Related Devices (Code: HET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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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