Cleared Traditional

K161514 - Precision Thin Reciprocating Blade, 0.010in. (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K161514 · Stryker Corporation · Ear, Nose, Throat device
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Jan 2017
Decision
229d
Days
Class 1
Risk

K161514 is an FDA 510(k) clearance for the Precision Thin Reciprocating Blade, 0.010in.. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on January 17, 2017 after a review of 229 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - 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.

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Submission Details

510(k) Number K161514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date January 17, 2017
Days to Decision 229 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 89d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.