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FDA 510(k)

LAGIS 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)

K-Number: K240334 · 2024-10-30

ApplicantLagis Enterprise Co., Ltd.
Decision Date2024-10-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAGIS 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) is a medical device manufactured by Lagis Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2024-10-30 under approval number K240334. 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 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)?

LAGIS 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) is a medical device that received FDA 510(k) clearance on 2024-10-30. It is manufactured by Lagis Enterprise Co., Ltd.. The 510(k) number is K240334.

When was LAGIS 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) approved by the FDA?

LAGIS 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) received FDA 510(k) clearance on 2024-10-30, under approval number K240334.

What company makes LAGIS 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)?

LAGIS 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) is manufactured by Lagis Enterprise Co., Ltd..

What is the FDA product code for LAGIS 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)?

The FDA product code for LAGIS 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) is GCJ.

Related Clinical Trials

NCT07568366 AI in Endoscopic Transsphenoidal Surgery NOT_YET_RECRUITING NCT05272046 Monopolar and Bipolar Current RFA Knife in POEM ACTIVE_NOT_RECRUITING

Other Devices by Lagis Enterprise Co., Ltd.

K243867LAGIS Suction Irrigation System

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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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