Cleared Traditional

K983964 - BATCH #6060 CONDUCTIVE GEL

K983964 is an FDA 510(k) clearance for BATCH #6060 CONDUCTIVE GEL, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K983964 · Skylark Device Co., Ltd. · Neurology device
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Dec 1998
Decision
33d
Days
Class 2
Risk

K983964 is an FDA 510(k) clearance for the BATCH #6060 CONDUCTIVE GEL. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on December 9, 1998 after a review of 33 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. 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K983964

510(k) Number K983964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1998
Decision Date December 09, 1998
Days to Decision 33 days
Submission Type Traditional
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
115d faster than avg
Panel avg: 148d · This submission: 33d
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 30
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