Sinusway Dilation System— 510(k) K181838

Name: FDA 510(k) clearance K181838
Creator: U.S. Food and Drug Administration
Published: 2018-12-20

Substantially Equivalent

3nt Medical , Ltd.

FDA 510(k) clearance K181838 for Sinusway Dilation System, Substantially Equivalent on 2018-12-20. Applicant: 3nt Medical , Ltd.. Device class: 1.

Clearance details

Applicant: 3nt Medical , Ltd.
Product code: Code LRC
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 2018-07-10
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosh Ha'Ayin, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.