Cleared Traditional

SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (K960372) - FDA 510(k) Clearance

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

K960372 · Scanlan Intl., Inc. · Neurology device
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Apr 1996
Decision
91d
Days
Class 2
Risk

K960372 is an FDA 510(k) clearance for the SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 91 days - within the typical 510(k) review window.

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. 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 Scanlan Intl., Inc. devices

Submission Details

510(k) Number K960372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1996
Decision Date April 26, 1996
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
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.

Regulatory Peers - HCH Clip, Aneurysm

All 35
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K960372.
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K043041 · Aesculap, Inc. · Dec 2004
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc. · Mar 2003