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FDA 510(k)

Single Use Irrigation bipolar cable

K-Number: K211170 · 2021-10-19

ApplicantModern Medical Equipment Manufacturing, Ltd.
Decision Date2021-10-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single Use Irrigation bipolar cable is a medical device manufactured by Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2021-10-19 under approval number K211170. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Irrigation bipolar cable?

Single Use Irrigation bipolar cable is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K211170.

When was Single Use Irrigation bipolar cable approved by the FDA?

Single Use Irrigation bipolar cable received FDA 510(k) clearance on 2021-10-19, under approval number K211170.

What company makes Single Use Irrigation bipolar cable?

Single Use Irrigation bipolar cable is manufactured by Modern Medical Equipment Manufacturing, Ltd..

What is the FDA product code for Single Use Irrigation bipolar cable?

The FDA product code for Single Use Irrigation bipolar cable is GEI.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT07563257 Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation NOT_YET_RECRUITING NCT06649357 Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate RECRUITING NCT07192172 Enhanced Radiofrequency Ablation for Recurrent HCC Post-TACE Using Twin Internally Cooled-Perfusion Electrodes COMPLETED

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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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