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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 the device name listed in this FDA 510(k) record. The listed applicant is New View Surgical, Inc.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) 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. The listed applicant is New View Surgical, Inc.. The 510(k) number is K211250.

When did VisionPort System receive FDA 510(k) clearance?

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

Who is the listed applicant for VisionPort System?

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

What is the FDA product code for VisionPort System?

The FDA product code for VisionPort System is GCJ.

Related Devices (Code: GCJ)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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.

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