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FDA 510(k)

VS3 Iridium Sytem

K-Number: K210265 · 2021-11-22

ApplicantVisionsense, Ltd.
Decision Date2021-11-22
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VS3 Iridium Sytem is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K210265. 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 Sytem?

VS3 Iridium Sytem is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Visionsense, Ltd.. The 510(k) number is K210265.

When did VS3 Iridium Sytem receive FDA 510(k) clearance?

VS3 Iridium Sytem received FDA 510(k) clearance on 2021-11-22, under 510(k) number K210265.

Who is the listed applicant for VS3 Iridium Sytem?

The FDA 510(k) record lists Visionsense, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VS3 Iridium Sytem?

The FDA product code for VS3 Iridium Sytem is OWN.

Other records listing Visionsense, Ltd. 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.

K223020VS3-Iridium System (VS3-IR)K171208Trans-anal IntroducerK153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

Related Devices (Code: OWN)

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.

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Official Source

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