Cleared Traditional

K964433 - AQUABOND ELECTRODE

K964433 is an FDA 510(k) clearance for AQUABOND ELECTRODE, manufactured by Medibond , Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K964433 · Medibond , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
83d
Days
Class 2
Risk

K964433 is an FDA 510(k) clearance for the AQUABOND ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medibond , Ltd. (Efrat, IL). The FDA issued a Cleared decision on January 27, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

FDA 510(k) Submission Details - K964433

510(k) Number K964433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date January 27, 1997
Days to Decision 83 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
66d faster than avg
Panel avg: 149d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 379
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K964433.
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K964433 · AQUABOND ELECTRODE
Download PDF FDA Summary Medibond , Ltd.