BB 8 Sinus Dilation Kit— 510(k) K230258

Name: FDA 510(k) clearance K230258
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Substantially Equivalent

Excelent, Inc.

FDA 510(k) clearance K230258 for BB 8 Sinus Dilation Kit, Substantially Equivalent on 2023-05-25. Applicant: Excelent, Inc.. Device class: 1.

Clearance details

Applicant: Excelent, Inc.
Product code: Code LRC
Device class: Class 1
Regulation: 21 CFR 874.4420
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 ↗

Recent devices under product code LRC

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K212774 — VenSure LightGuide2022-02-04
K201398 — SINUSPRIME Dilation System2020-10-15
K201115 — Next Generation Balloon Dilation System2020-08-27
K201472 — VenSure Balloon Device, VenSure Nav Balloon Device2020-08-26
K181546 — Dillard Nasal Balloon Catheter2020-01-03

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.