# K081489: L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil Aneurysm Clip Appliers

- Pathway: 510(k) (Traditional)
- Applicant: Peter Lazic GmbH
- Decided: Sep 25, 2008 after 120 days
- Product code: HCH (Clip, Aneurysm)
- Device class: 2
- Regulation: 21 CFR 882.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KIRWAN L-Aneurysm Clips and Appliers: named in the summary without a submission number
- (no number) REBSTOCK Aneurysm Clips: named in the summary without a submission number
- (no number) Perneczky Aneurysm Clips: named in the summary without a submission number
- (no number) Perneczky Clip Applier/Remover: named in the summary without a submission number
- (no number) Yasargil Clip Appliers: named in the summary without a submission number

## Recalls of this device
- Jul 14, 2023 · Class II · Z-1288-2024: Wrong product coloring. The paddle clips should be blank, but they are colored blue.
- Jul 14, 2023 · Class II · Z-1287-2024: Wrong product coloring. The paddle clips should be blank, but they are colored blue.

## Indications for use
Permanent L-Aneurysm-Clips and YASARGIL aneurysm and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary L-Aneurysm-Clips and Yasargil aneurysm and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms. The L-Aneurysm-Clip Appliers are intended to be used for holding and applying L-Aneurysm-Clips. The Yasargil-Aneurysm-Clip Appliers are intended to be used for holding and applying Yasargil-Aneurysm-Clips. The L-Aneurysm-Clip Appliers and the Yasargil-Aneurysm-Clip Appliers are not compatible to other traded systems.

Source page: https://510kreport.com/device/K081489
Methodology: https://510kreport.com/methodology