Cleared Special

K071185 - MODIFICATION TO: AMBU NEUROLINE

K071185 is the FDA 510(k) clearance for MODIFICATION TO: AMBU NEUROLINE by Ambu A/S. It is a Class 2 Neurology device (product code GXZ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K071185 · Ambu A/S · Neurology device
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May 2007
Decision
30d
Days
Class 2
Risk

K071185 is an FDA 510(k) clearance for the MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on May 30, 2007 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ambu A/S devices

Submission Details

510(k) Number K071185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date May 30, 2007
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 14
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K071185.
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
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc. · Apr 1994