Cleared Traditional

K112231 - LCCS INSULATED SPINAL NEEDLE (RF CANNULA)

K112231 is an FDA 510(k) clearance for LCCS INSULATED SPINAL NEEDLE (RF CANNULA), 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 15-day FDA review.

K112231 · Lccs Products Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
15d
Days
Class 2
Risk

K112231 is an FDA 510(k) clearance for the LCCS INSULATED SPINAL NEEDLE (RF CANNULA). Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Lccs Products Limited (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on August 19, 2011 after a review of 15 days - a notably fast clearance cycle.

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: 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 Lccs Products Limited devices

FDA 510(k) Submission Details - K112231

510(k) Number K112231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2011
Decision Date August 19, 2011
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
NED DEVINE

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 K112231.
OWL CANNULAE
K141586 · Diros Technology, Inc. · Dec 2014
STRYKER VENOM ELECTRODES AND CANNULAE
K123178 · Stryker Instruments, Instruments Div. · Mar 2013
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773 · Biomerics · Sep 2012
OWL RF PROBES
K110593 · Diros Technology, Inc. · May 2011
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc. · Aug 2010
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · Baylis Medical Co., Inc. · Oct 2009