Vent-Os Sinus Dilation family— 510(k) K160770

Name: FDA 510(k) clearance K160770
Creator: U.S. Food and Drug Administration
Published: 2016-06-29

Substantially Equivalent

Sinusys Corporation

FDA 510(k) clearance K160770 for Vent-Os Sinus Dilation family, Substantially Equivalent on 2016-06-29. Applicant: Sinusys Corporation. Device class: 1.

Clearance details

Applicant: Sinusys Corporation
Product code: Code LRC
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 2016-03-21
Decision date: 2016-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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K133016 — VENT-OS SINUS DILATION SYSTEM2013-12-09

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.