Cleared Traditional

K102862 - NEUROVISION SE (NERVEANA)

K102862 is an FDA 510(k) clearance for NEUROVISION SE (NERVEANA), manufactured by Neurovision Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K102862 · Neurovision Medical Products, Inc. · Ear, Nose, Throat device
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Dec 2010
Decision
82d
Days
Class 2
Risk

K102862 is an FDA 510(k) clearance for the NEUROVISION SE (NERVEANA). Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 82 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neurovision Medical Products, Inc. devices

FDA 510(k) Submission Details - K102862

510(k) Number K102862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date December 21, 2010
Days to Decision 82 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
7d faster than avg
Panel avg: 89d · This submission: 82d
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 43
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K102862.
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