Cleared Traditional

Eustachi Ear Pressure Relief Device

K203754 · Exercore, LLC · Ear, Nose, Throat

Feb 2021

Decision

58d

Days

—

Risk

About This 510(k) Submission

K203754 is an FDA 510(k) clearance for the Eustachi Ear Pressure Relief Device, a Device, Inflation, Middle Ear, submitted by Exercore, LLC (Shakopee, US). The FDA issued a Cleared decision on February 19, 2021, 58 days after receiving the submission on December 23, 2020. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number	K203754 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2020
Decision Date	February 19, 2021
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF