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FDA 510(k)

VS3-Iridium System (VS3-IR)

K-Number: K223020 · 2022-10-28

ApplicantVisionsense, Ltd.
Decision Date2022-10-28
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VS3-Iridium System (VS3-IR) is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) 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. The listed applicant is Visionsense, Ltd.. The 510(k) number is K223020.

When did VS3-Iridium System (VS3-IR) receive FDA 510(k) clearance?

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

Who is the listed applicant for VS3-Iridium System (VS3-IR)?

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 System (VS3-IR)?

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

K210265VS3 Iridium SytemK171208Trans-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.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

Official Source

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