Cleared Special

K002871 - MODIFICATION TO YASARGIL ANEURYSM CLIPS

K002871 is the FDA 510(k) clearance for MODIFICATION TO YASARGIL ANEURYSM CLIPS by Aesculap, Inc.. It is a Class 2 Neurology device (product code HCH) cleared through the Special 510(k) pathway after a 29-day FDA review.

K002871 · Aesculap, Inc. · Neurology device
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Oct 2000
Decision
29d
Days
Class 2
Risk

K002871 is an FDA 510(k) clearance for the MODIFICATION TO YASARGIL ANEURYSM CLIPS. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 13, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K002871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2000
Decision Date October 13, 2000
Days to Decision 29 days
Submission Type Special
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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 17
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K002871.
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc. · Mar 2003
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc. · Jan 2001
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · Aesculap, Inc. · Dec 1998
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc. · Nov 1997
SUNDT SLIM-LINE GRAFT CLIPS
K912456 · Codman & Shurtleff, Inc. · Mar 1995