# K013136: Aneurysm Clips

- Pathway: 510(k) (Traditional)
- Applicant: Gistlstrasse
- Decided: Nov 26, 2001 after 68 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
Longest line of descent: 3 generations back to K772200 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983758: Yasargil Titanium Aneurysm Clips, Aesculap, Inc. (1998) Summary page 1.
- K955064: Spetzler TI 100 Aneurysm Clip, Elekta Instruments, Inc. (1996) Summary page 1.
- K760771: Sola Schultze-Crock Opthalmoscope, Codman & Shurtleff, Inc. (1976) Summary page 1.

## Cited in the summary but kept off the family tree
- K782040: Sugita Aneurysm clips. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Pemeczky Titanium Aneurysm Clips are devices used to occlude an intracranial aneurysm (a balloon like sac formed on a blood vessel) to prevent it from bleeding or bursting. These titanium alloy aneurysm clips will be available as temporary or permanent devices.

Source page: https://510kreport.com/device/K013136
Methodology: https://510kreport.com/methodology