# K990202: Sugita Titanium Aneurysm Clip

- Pathway: 510(k) (Traditional)
- Applicant: Mizuho America, Inc.
- Decided: Jun 4, 1999 after 134 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
Longest line of descent: 3 generations back to K772200 (1977). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970050: Yasargil Titanium Aneurysm Clips (Ftxxxt), Aesculap, Inc. (1997) Summary page 1.
- P820009: Lincoff-Design Scleral Buckling Balloon Catheter, Bausch & Lomb (1983) Summary page 1.
- K955064: Spetzler TI 100 Aneurysm Clip, Elekta Instruments, Inc. (1996) Summary page 1.

## Recalls of this device
- Oct 10, 2013 · Class II · Z-0378-2014: Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
- Oct 10, 2013 · Class II · Z-0377-2014: Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

## Indications for use
The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.

Source page: https://510kreport.com/device/K990202
Methodology: https://510kreport.com/methodology