Cleared Traditional

K150220 - STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 149d · 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 Consultant

Navigant Consulting, Inc.
Allison Scott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 107
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