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FDA 510(k)

Envision 3D: Image Guidance System

K-Number: K162375 · 2016-12-29

Applicant7D Surgical, Inc.
Decision Date2016-12-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Envision 3D: Image Guidance System is a medical device manufactured by 7D Surgical, Inc.. It received FDA 510(k) clearance on 2016-12-29 under approval number K162375. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Envision 3D: Image Guidance System?

Envision 3D: Image Guidance System is a medical device that received FDA 510(k) clearance on 2016-12-29. It is manufactured by 7D Surgical, Inc.. The 510(k) number is K162375.

When was Envision 3D: Image Guidance System approved by the FDA?

Envision 3D: Image Guidance System received FDA 510(k) clearance on 2016-12-29, under approval number K162375.

What company makes Envision 3D: Image Guidance System?

Envision 3D: Image Guidance System is manufactured by 7D Surgical, Inc..

What is the FDA product code for Envision 3D: Image Guidance System?

The FDA product code for Envision 3D: Image Guidance System is OLO.

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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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