Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Lagis Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2025-03-17 under approval 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. It is manufactured by Lagis Enterprise Co., Ltd.. The 510(k) number is K243867.

When was LAGIS Suction Irrigation System approved by the FDA?

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

What company makes LAGIS Suction Irrigation System?

LAGIS Suction Irrigation System is manufactured by Lagis Enterprise Co., Ltd..

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

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

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED NCT07527702 Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection RECRUITING NCT06443970 Low and High Flow Suctioning in Intubated Infants RECRUITING NCT05975359 Assessment of the Interi Manifold in Implant-Based Breast Reconstruction RECRUITING NCT07510685 Closed-System Bladder Irrigation to Reduce Urinary Tract Infections After Endoscopic Urologic Surgery (IRIS Trial) COMPLETED

Other Devices by Lagis Enterprise Co., Ltd.

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)

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

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.

↑