FDA 510(k)

SmartSurgN Visualization System

Número K: K213943 · 2022-11-29

Data da decisão2022-11-29

Código do produtoOWN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartSurgN Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Smartsurgn Incorporated. It received FDA 510(k) clearance on 2022-11-29 under 510(k) number K213943. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartSurgN Visualization System?

SmartSurgN Visualization System is a medical device that received FDA 510(k) clearance on 2022-11-29. The listed applicant is Smartsurgn Incorporated. The 510(k) number is K213943.

When did SmartSurgN Visualization System receive FDA 510(k) clearance?

SmartSurgN Visualization System received FDA 510(k) clearance on 2022-11-29, under 510(k) number K213943.

Who is the listed applicant for SmartSurgN Visualization System?

The FDA 510(k) record lists Smartsurgn Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartSurgN Visualization System?

The FDA product code for SmartSurgN Visualization System is OWN.

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