Cleared Traditional

K142022 - MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K142022 · Medline Renewal · Ear, Nose, Throat device
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Dec 2014
Decision
147d
Days
Class 1
Risk

K142022 is an FDA 510(k) clearance for the MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES. Classified as Microdebrider, Ent, High Speed, Single Use, Reprocessed (product code NLY), Class I - General Controls.

Submitted by Medline Renewal (Redmond, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 147 days - within the typical 510(k) review window.

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 K142022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date December 19, 2014
Days to Decision 147 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
58d slower than avg
Panel avg: 89d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NLY Microdebrider, Ent, High Speed, Single Use, Reprocessed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
Definition Ent Microdebrider Is An Accessory To An Ent Drill System. It Is Intended To Remove Soft And Hard Tissue During Ear, Nost And Throat Surgery. These Devices Operate At High Speed For Precise Tissue Resection. (this Is For Reprocessed Sing Use Ent Microdebrider.)
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.