Cleared Traditional

K150220 - STM 9000 Basic

K150220 is an FDA 510(k) clearance for STM 9000 Basic, manufactured by Eb Neuro S.P.A.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K150220 · Eb Neuro S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
201d
Days
Class 2
Risk

K150220 is an FDA 510(k) clearance for the STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Eb Neuro S.P.A. (Florence, IT). The FDA issued a Cleared decision on August 19, 2015 after a review of 201 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eb Neuro S.P.A. devices

FDA 510(k) Submission Details - K150220

510(k) Number K150220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2015
Decision Date August 19, 2015
Days to Decision 201 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 148d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 61
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NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009