Cleared Traditional

BB 8 Sinus Dilation Kit

K230258 · Excelent, Inc. · Ear, Nose, Throat

May 2023

Decision

114d

Days

Class 1

Risk

About This 510(k) Submission

K230258 is an FDA 510(k) clearance for the BB 8 Sinus Dilation Kit, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Excelent, Inc. (Durham, US). The FDA issued a Cleared decision on May 25, 2023, 114 days after receiving the submission on January 31, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K230258 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2023
Decision Date	May 25, 2023
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF