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FDA 510(k)

LAGIS Suction Irrigation System

K-Number: K243867 · 2025-03-17

ApplicantLagis Enterprise Co., Ltd.
Decision Date2025-03-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAGIS Suction Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Lagis Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K243867. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAGIS Suction Irrigation System?

LAGIS Suction Irrigation System is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Lagis Enterprise Co., Ltd.. The 510(k) number is K243867.

When did LAGIS Suction Irrigation System receive FDA 510(k) clearance?

LAGIS Suction Irrigation System received FDA 510(k) clearance on 2025-03-17, under 510(k) number K243867.

Who is the listed applicant for LAGIS Suction Irrigation System?

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

What is the FDA product code for LAGIS Suction Irrigation System?

The FDA product code for LAGIS Suction Irrigation System is GCJ.

Other records listing Lagis Enterprise 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.

K253134LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)K240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)

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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.

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