Cleared Special

K071185 - MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

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

K071185 · Ambu A/S · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K071185

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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K071185.
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
SUBDERMAL NEEDLE ELECTRODES
K072276 · Xian Friendship Electronics Co., Ltd. · May 2008
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
K063729 · Technomed Europe · Aug 2007
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
K062996 · Axon Systems, Inc. · Jan 2007
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K062880 · Ives Eeg Solutions, Inc. · Dec 2006
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
K060189 · Ives Eeg Solutions, Inc. · May 2006
K071185 · MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
Download PDF FDA Summary Ambu A/S