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FDA 510(k)

Vent-Os Sinus Dilation family

K-Number: K160770 · 2016-06-29

ApplicantSinusys Corporation
Decision Date2016-06-29
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Vent-Os Sinus Dilation family is the device name listed in this FDA 510(k) record. The listed applicant is Sinusys Corporation. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160770. 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 family?

Vent-Os Sinus Dilation family is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Sinusys Corporation. The 510(k) number is K160770.

When did Vent-Os Sinus Dilation family receive FDA 510(k) clearance?

Vent-Os Sinus Dilation family received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160770.

Who is the listed applicant for Vent-Os Sinus Dilation family?

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 family?

The FDA product code for Vent-Os Sinus Dilation family is LRC.

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.

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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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