Cleared Special

K043041 - AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)

K043041 is an FDA 510(k) clearance for AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM..., manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HCH cleared through the Special 510(k) pathway after a 35-day FDA review.

K043041 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
35d
Days
Class 2
Risk

K043041 is an FDA 510(k) clearance for the AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX). 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 December 9, 2004 after a review of 35 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.

FDA 510(k) Submission Details - K043041

510(k) Number K043041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2004
Decision Date December 09, 2004
Days to Decision 35 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
114d faster than avg
Panel avg: 149d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 35
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K043041.
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
K081640 · Gimmi GmbH · May 2009
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
K081489 · Peter Lazic GmbH · Sep 2008
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
K060915 · Kirwan Surgical Products, Inc. · Apr 2007
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · Cardinalhealth · Jun 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc. · Mar 2003
K043041 · AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
Download PDF FDA Summary Aesculap, Inc.