Cleared Traditional

AUSTIN ENDOLYMPH DISPERSMENT SHUNT

K834094 · Treace Medical, Inc. · Ear, Nose, Throat

Sep 1984

Decision

297d

Days

Class 2

Risk

About This 510(k) Submission

K834094 is an FDA 510(k) clearance for the AUSTIN ENDOLYMPH DISPERSMENT SHUNT, a Tube, Shunt, Endolymphatic (Class II — Special Controls, product code ESZ), submitted by Treace Medical, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1984, 297 days after receiving the submission on November 28, 1983. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3820.

Submission Details

510(k) Number	K834094 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 1983
Decision Date	September 20, 1984
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—