Cleared Traditional

K041897 - MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041897 · Schaerer Mayfield USA, Inc. · Neurology device
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Jun 2005
Decision
322d
Days
Class 2
Risk

K041897 is an FDA 510(k) clearance for the MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Schaerer Mayfield USA, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 1, 2005 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Schaerer Mayfield USA, Inc. devices

Submission Details

510(k) Number K041897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2004
Decision Date June 01, 2005
Days to Decision 322 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 148d · This submission: 322d
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 422
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