XprESS Multi-Sinus Dilation System— 510(k) K152434
Substantially EquivalentEntellus Medical, Inc.
FDA 510(k) clearance K152434 for XprESS Multi-Sinus Dilation System, Substantially Equivalent on 2015-11-20. Applicant: Entellus Medical, Inc..
Clearance details
- Applicant
- Entellus Medical, Inc.
- Product code
- Code LRC
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code LRC
product code LRC- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.