FDA 510(k)

SmartSurgN Visualization System

K-Number: K213943 · 2022-11-29

Decision Date2022-11-29

Product CodeOWN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the SmartSurgN Visualization System?

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

When was SmartSurgN Visualization System approved by the FDA?

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

What company makes SmartSurgN Visualization System?

SmartSurgN Visualization System is manufactured by Smartsurgn Incorporated.

What is the FDA product code for SmartSurgN Visualization System?

The FDA product code for SmartSurgN Visualization System is OWN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.