XPRESS MULTI-SINUS DILATION TOOL— 510(k) K112506

Name: FDA 510(k) clearance K112506
Creator: U.S. Food and Drug Administration
Published: 2011-12-21

Substantially Equivalent

Entellus Medical, Inc.

FDA 510(k) clearance K112506 for XPRESS MULTI-SINUS DILATION TOOL, Substantially Equivalent on 2011-12-21. Applicant: Entellus Medical, Inc.. Device class: 1.

Clearance details

Applicant: Entellus Medical, Inc.
Product code: Code LRC
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 2011-08-30
Decision date: 2011-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

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.