Cleared Traditional

K041897 - MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01

K041897 is an FDA 510(k) clearance for MAYFIELD ACCISS II IMAGE GUIDED SURGERY..., manufactured by Schaerer Mayfield USA, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K041897 · Schaerer Mayfield USA, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K041897

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 149d · This submission: 322d
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 426
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K041897 · MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
Download PDF FDA Summary Schaerer Mayfield USA…