# K081640: Gimmi Aneurysm Clips and Applying Forceps

- Pathway: 510(k) (Abbreviated)
- Applicant: Gimmi GmbH
- Decided: May 6, 2009 after 329 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) Aesculap, Inc: named in the summary without a submission number
- (no number) Rebstock - Instrumente GmbH: named in the summary without a submission number
- (no number) V. Mueller Neuro/Spine: named in the summary without a submission number
- (no number) Cardinal Health: named in the summary without a submission number
- (no number) Medicon, E.G.: named in the summary without a submission number
- (no number) Kirwan Surgical Products, Inc: named in the summary without a submission number

## Indications for use
Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.

Source page: https://510kreport.com/device/K081640
Methodology: https://510kreport.com/methodology