Cleared Traditional

K960591 - RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237...

K960591 is an FDA 510(k) clearance for RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237..., manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K960591 · Chalgren Enterprises, Inc. · Neurology device
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Jun 1996
Decision
122d
Days
Class 2
Risk

K960591 is an FDA 510(k) clearance for the RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,23.... Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K960591

510(k) Number K960591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date June 13, 1996
Days to Decision 122 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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

All 17
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K960591.
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825 · Ambu A/S · Jan 2010
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · Ambu A/S · Jul 2007
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
K982950 · Chalgren Enterprises, Inc. · Jun 1999
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
K955335 · Chalgren Enterprises, Inc. · Jan 1996
RE-USABLE MONOPOLAR NEEDLE
K953886 · Chalgren Enterprises, Inc. · Oct 1995
RE-USABLE CONCENTRIC NEEDLE
K953887 · Chalgren Enterprises, Inc. · Oct 1995