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FDA 510(k)

Sinusway Dilation System

K-Number: K181838 · 2018-12-20

Applicant3nt Medical , Ltd.
Decision Date2018-12-20
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sinusway Dilation System is a medical device manufactured by 3nt Medical , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under approval number K181838. 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 Sinusway Dilation System?

Sinusway Dilation System is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by 3nt Medical , Ltd.. The 510(k) number is K181838.

When was Sinusway Dilation System approved by the FDA?

Sinusway Dilation System received FDA 510(k) clearance on 2018-12-20, under approval number K181838.

What company makes Sinusway Dilation System?

Sinusway Dilation System is manufactured by 3nt Medical , Ltd..

What is the FDA product code for Sinusway Dilation System?

The FDA product code for Sinusway Dilation System is LRC.

Related Clinical Trials

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Related Devices (Code: LRC)

K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. K160770Vent-Os Sinus Dilation familySinusys Corporation K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc. K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.

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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