Cleared Traditional

K003924 - MAVIDON MEDICAL ELECTRODE JELLY

K003924 is an FDA 510(k) clearance for MAVIDON MEDICAL ELECTRODE JELLY, manufactured by Mavidon Medical Products. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K003924 · Mavidon Medical Products · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
247d
Days
Class 2
Risk

K003924 is an FDA 510(k) clearance for the MAVIDON MEDICAL ELECTRODE JELLY. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Mavidon Medical Products (Lake Worth, US). The FDA issued a Cleared decision on August 24, 2001 after a review of 247 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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.

FDA 510(k) Submission Details - K003924

510(k) Number K003924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2000
Decision Date August 24, 2001
Days to Decision 247 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
98d slower than avg
Panel avg: 149d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 61
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K003924.
LEKTROGEL, MODEL LK3001
K030887 · Inmed Ltda. · Jun 2003
HOME CARE JELLY
K022494 · Roc Chinese-European Industrial Research Society · Dec 2002
CONDUCTIVE GEL
K022006 · The Dezac Group · Sep 2002
CONDUCTIVE GEL FOR ULTRASOUND
K002832 · Skylark Device & Systems Co., Ltd. · Aug 2001
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
K001705 · Chester Labs, Inc. · Jun 2000
BATCH #6060 CONDUCTIVE GEL
K983964 · Skylark Device Co., Ltd. · Dec 1998
K003924 · MAVIDON MEDICAL ELECTRODE JELLY
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