FDA 510(k)

Envision 3D: Image Guidance System

K-Number: K162375 · 2016-12-29

Decision Date2016-12-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Envision 3D: Image Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2016-12-29 under 510(k) 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. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K162375.

When did Envision 3D: Image Guidance System receive FDA 510(k) clearance?

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

Who is the listed applicant for Envision 3D: Image Guidance System?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing 7D Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2205227D Surgical System - Percutaneous Application (7D Flash Frame)K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key K2105557D Surgical System - Drill Guide K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application K1921407D Surgical System

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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.