Cleared Traditional

K152642 - LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

K152642 is an FDA 510(k) clearance for LCCS Disposable RF Electrode, manufactured by Lccs Products Limited. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K152642 · Lccs Products Limited · Neurology device
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Aug 2016
Decision
346d
Days
Class 2
Risk

K152642 is an FDA 510(k) clearance for the LCCS Disposable RF Electrode, LCCS Reusable RF Electrode. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Lccs Products Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 26, 2016 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - 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. Elevated predicate reliance profile. 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 Lccs Products Limited devices

FDA 510(k) Submission Details - K152642

510(k) Number K152642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date August 26, 2016
Days to Decision 346 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
198d slower than avg
Panel avg: 148d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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

Shenzhen Joyantech Consulting Co., Ltd.
FIELD FU

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.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 53
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K152642.
OWL RF INSULATED CANNULAE
K170708 · Diros Technology, Inc. · Jun 2017
Coolief* Cooled RF Probe
K163461 · Halyard Health, Inc. · Apr 2017
COOLIEF Cooled Radiofrequency Kit
K163236 · Halyard Health, Inc. · Dec 2016
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K153272 · Relievant Medsystems · Jul 2016
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
K150371 · Diros Technology, Inc. · Jul 2015
OWL CANNULAE
K141586 · Diros Technology, Inc. · Dec 2014