Sugita Titanium Aneurysm Clip

by Mizuho America, Inc. 510(k)

Active United States

510(k) K990202

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK990202	Date4 Jun 1999Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

2 recalls, same reason
- Terminated Z-0377-2014 FDA Class II initiated 10 Oct 2013
- Terminated Z-0378-2014 FDA Class II initiated 10 Oct 2013
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

Specification

510(k)

510(k) Number: K990202
FDA Product Code: HCH

Device Class: Class II
Regulation: 21 CFR Part 882.5200
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

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