Cleared Traditional

K192603 - Spes Medica Subdermal Needle Electrodes

K192603 is an FDA 510(k) clearance for Spes Medica Subdermal Needle Electrodes, manufactured by Spes Medica Srl. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K192603 · Spes Medica Srl · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
63d
Days
Class 2
Risk

K192603 is an FDA 510(k) clearance for the Spes Medica Subdermal Needle Electrodes. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Spes Medica Srl (Battipaglia (Sa), IT). The FDA issued a Cleared decision on November 22, 2019 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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: 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 Spes Medica Srl devices

FDA 510(k) Submission Details - K192603

510(k) Number K192603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2019
Decision Date November 22, 2019
Days to Decision 63 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
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 16
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K192603.
Medical Disposable Sterile Needle Electrode
K232581 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023
Phantom XL Insulated Dilators
K231691 · TeDan Surgical Innovations, Inc. · Jun 2023
Guardian Needle Electrode
K200984 · Rhythmlink International, LLC · May 2020
PressOn Electrode Headset
K190801 · Rhythmlink International, LLC · Jul 2019
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · Stryker Spine · Jul 2011
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008