Yasargil Titanium Aneurysm Clips
510(k) K983758
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983758 | Date18 Dec 1998 | StatusActive |
Official records
- FDA 510(k) database K983758
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCH
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5200
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Yasargil Titanium Aneurysm Clips are medical devices designed for the microsurgical treatment of cerebral aneurysms. These clips are crafted from titanium and are non-ferromagnetic, making them MRI-safe for use in 3-Tesla or less magnetic resonance imaging environments. The clips feature a pyramidal design that doubles the surface area available for contact with vascular tissue, and low profile blades that provide enhanced visualization of cerebral anatomy.
The Yasargil Aneurysm Clips are supplied as sterile, single-use devices. They are authorized under FDA 510K clearance with product code HCH and device class 2. The clips are available in various models and sizes, including those with 1.5 spring coils made from titanium. These devices are manufactured by Aesculap, Inc. and are intended for use in neurosurgical procedures.