# K060915: Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Apr 17, 2007 after 378 days
- Product code: HCH (Clip, Aneurysm)
- Device class: 2
- Regulation: 21 CFR 882.5200
- Recalls of this device: none
- 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) 65.XXX XT Series, REBSTOCK Implant Steel Aneurysm Clips & Titanium Aneurysm Clips: named in the summary without a submission number
- (no number) 55XXX Series, PERNECZKY ANEURYSM CLIP: named in the summary without a submission number
- (no number) FT XXX T Series / FE XXX K Series, AESCULAP YASARGIL ANEURYSM CLIP, (TITANIUM or PHYNOX): named in the summary without a submission number

## Indications for use
The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.

Source page: https://510kreport.com/device/K060915
Methodology: https://510kreport.com/methodology