Cleared Traditional

K072276 - SUBDERMAL NEEDLE ELECTRODES

K072276 is an FDA 510(k) clearance for SUBDERMAL NEEDLE ELECTRODES, manufactured by Xian Friendship Electronics Co., Ltd.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K072276 · Xian Friendship Electronics Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
275d
Days
Class 2
Risk

K072276 is an FDA 510(k) clearance for the SUBDERMAL NEEDLE ELECTRODES. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Xian Friendship Electronics Co., Ltd. (Haidian District, Beijing, CN). The FDA issued a Cleared decision on May 16, 2008 after a review of 275 days - an extended review 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: 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 Xian Friendship Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K072276

510(k) Number K072276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date May 16, 2008
Days to Decision 275 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
127d slower than avg
Panel avg: 148d · This submission: 275d
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 28
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K072276.
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · Stryker Spine · Jul 2011
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K100912 · Kirwan Surgical Products, Inc. · Aug 2010
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002