Cleared Abbreviated

HILGER DUAL-STIM NERVE STIMULATOR (K063560) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K063560 · Wr Medical Electronics Co. · Ear, Nose, Throat device
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Jan 2007
Decision
38d
Days
Class 2
Risk

K063560 is an FDA 510(k) clearance for the HILGER DUAL-STIM NERVE STIMULATOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Wr Medical Electronics Co. (Stoughton, US). The FDA issued a Cleared decision on January 5, 2007 after a review of 38 days - a notably fast clearance cycle.

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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Wr Medical Electronics Co. devices

Submission Details

510(k) Number K063560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2006
Decision Date January 05, 2007
Days to Decision 38 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 89d · This submission: 38d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K063560.
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