FDA 510(k)

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

Número K: K180752 · 2018-07-25

Data da decisão2018-07-25

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole is the device name listed in this FDA 510(k) record. The listed applicant is Corinth Medtech, Inc.. It received FDA 510(k) clearance on 2018-07-25 under 510(k) number K180752. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole?

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Corinth Medtech, Inc.. The 510(k) number is K180752.

When did Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole receive FDA 510(k) clearance?

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole received FDA 510(k) clearance on 2018-07-25, under 510(k) number K180752.

Who is the listed applicant for Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole?

The FDA 510(k) record lists Corinth Medtech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole?

The FDA product code for Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole is HIH.

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Outros registros que listam Corinth Medtech, Inc. como candidato(a)

K230205Veloxion System 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 K162979Veloxion System

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Fonte oficial

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