Cleared Traditional

K960097 - CHARTR EP

K960097 is an FDA 510(k) clearance for CHARTR EP, manufactured by Ics Medical Corp.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K960097 · Ics Medical Corp. · Neurology device
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Feb 1997
Decision
407d
Days
Class 2
Risk

K960097 is an FDA 510(k) clearance for the CHARTR EP. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on February 21, 1997 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Ics Medical Corp. devices

FDA 510(k) Submission Details - K960097

510(k) Number K960097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date February 21, 1997
Days to Decision 407 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
259d slower than avg
Panel avg: 148d · This submission: 407d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 41
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