Cleared Traditional

K081489 - L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS

K081489 is an FDA 510(k) clearance for L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLI..., manufactured by Peter Lazic GmbH. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K081489 · Peter Lazic GmbH · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2008
Decision
120d
Days
Class 2
Risk

K081489 is an FDA 510(k) clearance for the L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & .... Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Peter Lazic GmbH (Mühlheim An Der Donau, DE). The FDA issued a Cleared decision on September 25, 2008 after a review of 120 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 Peter Lazic GmbH devices

FDA 510(k) Submission Details - K081489

510(k) Number K081489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2008
Decision Date September 25, 2008
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 148d · This submission: 120d
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 29
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K081489.
D-Clip
K180757 · Peter Lazic GmbH · Apr 2019
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
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
K060915 · Kirwan Surgical Products, Inc. · Apr 2007
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
K043041 · Aesculap, Inc. · Dec 2004
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003