Cleared Traditional

Epi-Stop Nasal Gel/epistaxis pack

K230142 · Biomed Ent, Inc. · Ear, Nose, Throat

Mar 2023

Decision

63d

Days

Class 1

Risk

About This 510(k) Submission

K230142 is an FDA 510(k) clearance for the Epi-Stop Nasal Gel/epistaxis pack, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Biomed Ent, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 22, 2023, 63 days after receiving the submission on January 18, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number	K230142 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2023
Decision Date	March 22, 2023
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF