BB 8 Sinus Dilation Kit— 510(k) K230258

Substantially Equivalent

Excelent, Inc.

FDA 510(k) clearance K230258 for BB 8 Sinus Dilation Kit, Substantially Equivalent on 2023-05-25. Applicant: Excelent, Inc..

Clearance details

Applicant: Excelent, Inc.
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 2023-01-31
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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.