Cleared Traditional

YASARGIL FENESTRATED ANEURYSM CLIP & (K833652) - FDA 510(k) Clearance

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

K833652 · Advanced Biosearch Assn. · Neurology device
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Jan 1984
Decision
100d
Days
Class 2
Risk

K833652 is an FDA 510(k) clearance for the YASARGIL FENESTRATED ANEURYSM CLIP &. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Walker, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 100 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 Advanced Biosearch Assn. devices

Submission Details

510(k) Number K833652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1983
Decision Date January 27, 1984
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 148d · This submission: 100d
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 18
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K833652.
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995
YASARGIL ANEURYSM CLIPS
K922272 · Aesculap, Inc. · Sep 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · Aesculap, Inc. · Mar 1992
HEIFETZ INTRACRANIAL ANEURYSM CLIPS
K832795 · Edward Weck, Inc. · Nov 1983
SCOVILLE-LEWIS ANEURYSM CLIPS
K791764 · Codman & Shurtleff, Inc. · Oct 1979
HEIFETZ ANEURYSM CLIP, LMM BLADE
K790413 · Edward Weck, Inc. · Mar 1979