Cleared Traditional

K965065 - TECA. MILLENNIUM

K965065 is an FDA 510(k) clearance for TECA. MILLENNIUM, manufactured by Medelec , Ltd.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K965065 · Medelec , Ltd. · Neurology device
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Jun 1997
Decision
184d
Days
Class 2
Risk

K965065 is an FDA 510(k) clearance for the TECA. MILLENNIUM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Medelec , Ltd. (Surrey, England Gu22 9ju, GB). The FDA issued a Cleared decision on June 20, 1997 after a review of 184 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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.

View all Medelec , Ltd. devices

FDA 510(k) Submission Details - K965065

510(k) Number K965065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date June 20, 1997
Days to Decision 184 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
36d slower than avg
Panel avg: 148d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 92
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K965065.
AMPLAID MK12
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K971819 · Axon Systems, Inc. · Nov 1997
GALILEO EVOKED POTENTIALRE
K963662 · Biosound, Inc. · Feb 1997
FOUR-CHANNEL PREAMPLIFIER
K962455 · Cadwell Laboratories, Inc. · Jan 1997
TWO-CHANNEL PREAMPLIFIER
K962457 · Cadwell Laboratories, Inc. · Jan 1997