Cleared Traditional

K013428 - MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM

K013428 is an FDA 510(k) clearance for MAYFIELD/ACCISS OPERATING ARM SYSTEM AN..., manufactured by Ohio Medical Instrument Co., Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K013428 · Ohio Medical Instrument Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
170d
Days
Class 2
Risk

K013428 is an FDA 510(k) clearance for the MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Ohio Medical Instrument Co., Inc. (Wrentham, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 170 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 Ohio Medical Instrument Co., Inc. devices

FDA 510(k) Submission Details - K013428

510(k) Number K013428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2001
Decision Date April 04, 2002
Days to Decision 170 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
22d slower than avg
Panel avg: 148d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

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 273
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