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FDA 510(k)

VENT-OS SINUS DILATION SYSTEM

K-Number: K133016 · 2013-12-09

ApplicantSinusys Corporation
Decision Date2013-12-09
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VENT-OS SINUS DILATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sinusys Corporation. It received FDA 510(k) clearance on 2013-12-09 under 510(k) number K133016. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENT-OS SINUS DILATION SYSTEM?

VENT-OS SINUS DILATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-09. The listed applicant is Sinusys Corporation. The 510(k) number is K133016.

When did VENT-OS SINUS DILATION SYSTEM receive FDA 510(k) clearance?

VENT-OS SINUS DILATION SYSTEM received FDA 510(k) clearance on 2013-12-09, under 510(k) number K133016.

Who is the listed applicant for VENT-OS SINUS DILATION SYSTEM?

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

What is the FDA product code for VENT-OS SINUS DILATION SYSTEM?

The FDA product code for VENT-OS SINUS DILATION SYSTEM is LRC.

Related Clinical Trials

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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Other records listing Sinusys Corporation 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.

K160770Vent-Os Sinus Dilation family

Related Devices (Code: LRC)

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.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLC

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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