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FDA 510(k)

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

K-Number: K131434 · 2013-07-16

ApplicantVisionsense, Ltd.
Decision Date2013-07-16
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2013-07-16 under 510(k) number K131434. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-16. The listed applicant is Visionsense, Ltd.. The 510(k) number is K131434.

When did VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM receive FDA 510(k) clearance?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM received FDA 510(k) clearance on 2013-07-16, under 510(k) number K131434.

Who is the listed applicant for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

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 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

The FDA product code for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is GWG.

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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)K210265VS3 Iridium SytemK171208Trans-anal IntroducerK153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMK123467VS3K082355VISIONSENSE STEREOSCOPIC VISION SYSTEM

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Related Devices (Code: GWG)

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.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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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