Cleared Traditional

K953568 - CODMAN FIDUCIAL MARKER SYSTEM

K953568 is the FDA 510(k) clearance for CODMAN FIDUCIAL MARKER SYSTEM by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K953568 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
213d
Days
Class 2
Risk

K953568 is an FDA 510(k) clearance for the CODMAN FIDUCIAL MARKER SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 213 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K953568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date February 29, 1996
Days to Decision 213 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
65d slower than avg
Panel avg: 148d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 186
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K953568.
PHILIPS EASYGUIDE NEURO
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BRAINLAB HEADPINS
K954789 · Brainlab AG · Aug 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961858 · Radionics, Inc. · Aug 1996
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd. · Aug 1986