Cleared Traditional

K960037 - SUGITA AVM MICROCLIP (FDA 510(k) Clearance)

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

K960037 · Mizuho America, Inc. · Neurology device
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Feb 1997
Decision
399d
Days
Class 2
Risk

K960037 is an FDA 510(k) clearance for the SUGITA AVM MICROCLIP. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Mizuho America, Inc. (Beverly, US). The FDA issued a Cleared decision on February 5, 1997 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - 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.

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Submission Details

510(k) Number K960037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1996
Decision Date February 05, 1997
Days to Decision 399 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
251d slower than avg
Panel avg: 148d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
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.