Cleared Traditional

K093373 - LARYNGEAL SURFACE ELECTRODE (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093373 · Spes Medica Srl · Ear, Nose, Throat device
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Aug 2010
Decision
299d
Days
Class 2
Risk

K093373 is an FDA 510(k) clearance for the LARYNGEAL SURFACE ELECTRODE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on August 24, 2010 after a review of 299 days - an extended review 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: 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 Spes Medica Srl devices

Submission Details

510(k) Number K093373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2009
Decision Date August 24, 2010
Days to Decision 299 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
210d slower than avg
Panel avg: 89d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K093373.
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