Cleared Special

K001705 - STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF

K001705 is an FDA 510(k) clearance for STATSIGN ELECTRODE CONDUCTIVITY GEL, manufactured by Chester Labs, Inc.. The device is a Class 2 Neurology device with product code GYB cleared through the Special 510(k) pathway after a 24-day FDA review.

K001705 · Chester Labs, Inc. · Neurology device
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Jun 2000
Decision
24d
Days
Class 2
Risk

K001705 is an FDA 510(k) clearance for the STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL,.... Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Chester Labs, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 29, 2000 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 - K001705

510(k) Number K001705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date June 29, 2000
Days to Decision 24 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 149d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 51
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K001705.
CONDUCTIVE GEL
K022006 · The Dezac Group · Sep 2002
MAVIDON MEDICAL ELECTRODE JELLY
K003924 · Mavidon Medical Products · Aug 2001
CONDUCTIVE GEL FOR ULTRASOUND
K002832 · Skylark Device & Systems Co., Ltd. · Aug 2001
BATCH #6060 CONDUCTIVE GEL
K983964 · Skylark Device Co., Ltd. · Dec 1998
MODEL 1700, HYDRO PREP
K970694 · Physiometrix, Inc. · May 1997
HYDROPREP GEL
K964737 · D.O. Weaver Co. · Mar 1997
K001705 · STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
Download PDF Chester Labs, Inc.