Cleared Traditional

K103128 - CADWELL DISPOSABLE MONOPOLAR / BIPOLAR ...

K103128 is an FDA 510(k) clearance for CADWELL DISPOSABLE MONOPOLAR / BIPOLAR ..., manufactured by Cadwell Lab, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K103128 · Cadwell Lab, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
121d
Days
Class 2
Risk

K103128 is an FDA 510(k) clearance for the CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PED.... Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Cadwell Lab, Inc. (Kennewick, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - 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 Cadwell Lab, Inc. devices

FDA 510(k) Submission Details - K103128

510(k) Number K103128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2010
Decision Date February 23, 2011
Days to Decision 121 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
32d slower than avg
Panel avg: 89d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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.

Regulatory Peers - ETN Stimulator, Nerve

All 42
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K103128.
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XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
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NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005