FDA 510(k)

VS3-Iridium System (VS3-IR)

K-Number: K223020 · 2022-10-28

Decision Date2022-10-28

Product CodeOWN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

VS3-Iridium System (VS3-IR) is a medical device manufactured by Visionsense, Ltd.. It received FDA 510(k) clearance on 2022-10-28 under approval number K223020. 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 VS3-Iridium System (VS3-IR)?

VS3-Iridium System (VS3-IR) is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Visionsense, Ltd.. The 510(k) number is K223020.

When was VS3-Iridium System (VS3-IR) approved by the FDA?

VS3-Iridium System (VS3-IR) received FDA 510(k) clearance on 2022-10-28, under approval number K223020.

What company makes VS3-Iridium System (VS3-IR)?

VS3-Iridium System (VS3-IR) is manufactured by Visionsense, Ltd..

What is the FDA product code for VS3-Iridium System (VS3-IR)?

The FDA product code for VS3-Iridium System (VS3-IR) is OWN.

Other Devices by Visionsense, Ltd.

K153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM K171208Trans-anal Introducer K210265VS3 Iridium Sytem

Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

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.