Cleared Special

K032198 - AESCULAP YASARGIL ANEURYSM CLIP PHYNOX ...

K032198 is the FDA 510(k) clearance for AESCULAP YASARGIL ANEURYSM CLIP PHYNOX ... by Aesculap, Inc.. It is a Class 2 Neurology device (product code HCH) cleared through the Special 510(k) pathway after a 33-day FDA review.

K032198 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
33d
Days
Class 2
Risk

K032198 is an FDA 510(k) clearance for the AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP. 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 August 20, 2003 after a review of 33 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 K032198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date August 20, 2003
Days to Decision 33 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
115d faster than avg
Panel avg: 148d · This submission: 33d
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 K032198.
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500 · Aesculap, Inc. · Jan 2014
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
K091921 · Codman & Shurtleff, Inc. · Sep 2009
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
K043041 · Aesculap, Inc. · Dec 2004
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc. · Mar 2003
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc. · Jan 2001
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · Aesculap, Inc. · Oct 2000