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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 the device name listed in this FDA 510(k) record. The listed applicant is 3nt Medical , Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) 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. The listed applicant is 3nt Medical , Ltd.. The 510(k) number is K181838.

When did Sinusway Dilation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Sinusway Dilation System?

The FDA 510(k) record lists 3nt Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sinusway Dilation System?

The FDA product code for Sinusway Dilation System is LRC.

Other records listing 3nt Medical , Ltd. as applicant

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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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