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FDA 510(k)

VisionPort System

K-Number: K211250 · 2021-06-21

ApplicantNew View Surgical, Inc.
Decision Date2021-06-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VisionPort System is a medical device manufactured by New View Surgical, Inc.. It received FDA 510(k) clearance on 2021-06-21 under approval number K211250. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisionPort System?

VisionPort System is a medical device that received FDA 510(k) clearance on 2021-06-21. It is manufactured by New View Surgical, Inc.. The 510(k) number is K211250.

When was VisionPort System approved by the FDA?

VisionPort System received FDA 510(k) clearance on 2021-06-21, under approval number K211250.

What company makes VisionPort System?

VisionPort System is manufactured by New View Surgical, Inc..

What is the FDA product code for VisionPort System?

The FDA product code for VisionPort System is GCJ.

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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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