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FDA 510(k)

Veloxion System

K-Number: K162979 · 2017-03-24

ApplicantCorinth Medtech, Inc.
Decision Date2017-03-24
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Veloxion System is a medical device manufactured by Corinth Medtech, Inc.. It received FDA 510(k) clearance on 2017-03-24 under approval number K162979. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Veloxion System?

Veloxion System is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Corinth Medtech, Inc.. The 510(k) number is K162979.

When was Veloxion System approved by the FDA?

Veloxion System received FDA 510(k) clearance on 2017-03-24, under approval number K162979.

What company makes Veloxion System?

Veloxion System is manufactured by Corinth Medtech, Inc..

What is the FDA product code for Veloxion System?

The FDA product code for Veloxion System is FJL.

Other Devices by Corinth Medtech, Inc.

K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch K230205Veloxion System

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Related Devices (Code: FJL)

K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc. K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc. K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. K230205Veloxion SystemCorinth Medtech, Inc. K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG

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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