Cleared Traditional

K913765 - YASARGIL ANEURYSM CLIPS, MODIFICATION

K913765 is an FDA 510(k) clearance for YASARGIL ANEURYSM CLIPS, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K913765 · Aesculap, Inc. · Neurology device
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Mar 1992
Decision
202d
Days
Class 2
Risk

K913765 is an FDA 510(k) clearance for the YASARGIL ANEURYSM CLIPS, MODIFICATION. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 11, 1992 after a review of 202 days - an extended review cycle.

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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K913765

510(k) Number K913765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1991
Decision Date March 11, 1992
Days to Decision 202 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 148d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCH Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K913765.
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
K960372 · Scanlan Intl., Inc. · Apr 1996
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995
YASARGIL ANEURYSM CLIPS
K922272 · Aesculap, Inc. · Sep 1992
YASARGIL FENESTRATED ANEURYSM CLIP &
K833652 · Advanced Biosearch Assn. · Jan 1984
YASARGIL STANDARD ANEURYSM CLIP &
K833650 · Advanced Biosearch Assn. · Jan 1984
HEIFETZ INTRACRANIAL ANEURYSM CLIPS
K832795 · Edward Weck, Inc. · Nov 1983