# K955064: Spetzler TI 100 Aneurysm Clip

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instruments, Inc.
- Decided: Oct 17, 1996 after 346 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: 1 generation back to K772200 (1977). 6 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K772200: Yasargil Aneurysm Clips, Aesculap Instruments Corp. (1977) Summary page 1.
- K913765: Yasargil Aneurysm Clips, Modification, Aesculap, Inc. (1992) Summary page 1.
- K922272: Yasargil Aneurysm Clips, Aesculap, Inc. (1992) Summary page 1.
- K791978: Sugita Aneurysm Clips, Appliers & Case, Codman & Shurtleff, Inc. (1979) Summary page 1.
- K881911: New Sizes Sugita Clips, Downs Surgical, Ltd. (1988) Summary page 1.
- K912456: Sundt Slim-Line Graft Clips, Codman & Shurtleff, Inc. (1995) Summary page 1.

## Most influential descendants
- K983758: Yasargil Titanium Aneurysm Clips (1998), 8 descendants of its own
- K984109: Aesculap Axial Clip Applier (1999), 6 descendants of its own
- K970050: Yasargil Titanium Aneurysm Clips (Ftxxxt) (1997), 6 descendants of its own
- K131500: Yasargil Aneurysm Clips and Clip Appliers (2014), 4 descendants of its own
- K173271: Aesculap Slim Clip Applier Forceps (2017), 3 descendants of its own

## Indications for use
The Spetzler Ti 100 Aneurysm Clips are intended for: Temporary occlusion of intracranial blood vessels/aneurysms Permanent placement in the brain for occlusion of intracranial aneurysms

Source page: https://510kreport.com/device/K955064
Methodology: https://510kreport.com/methodology