Cleared Traditional

K834094 - AUSTIN ENDOLYMPH DISPERSMENT SHUNT

K834094 is an FDA 510(k) clearance for AUSTIN ENDOLYMPH DISPERSMENT SHUNT, manufactured by Treace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ESZ cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K834094 · Treace Medical, Inc. · Ear, Nose, Throat device
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Sep 1984
Decision
297d
Days
Class 2
Risk

K834094 is an FDA 510(k) clearance for the AUSTIN ENDOLYMPH DISPERSMENT SHUNT. Classified as Tube, Shunt, Endolymphatic (product code ESZ), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 297 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3820 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Treace Medical, Inc. devices

FDA 510(k) Submission Details - K834094

510(k) Number K834094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 90d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ESZ Device Classification - Class 2, Special Controls

Product Code ESZ Tube, Shunt, Endolymphatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.