HCH · Clip, Aneurysm
Neurology · 21 CFR 882.5200 · Class 2
Overview
| Product Code | HCH |
|---|---|
| Device Name | Clip, Aneurysm |
| Regulation | 21 CFR 882.5200 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211183 | Sugita AVM Microclips | Mizuho America, Inc. | Mar 2, 2022 | SESE |
| K180757 | D-Clip; D-Clip Applier | Peter Lazic GmbH | Apr 12, 2019 | SESE |
| K131500 | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS | Aesculap, Inc. | Jan 24, 2014 | SESE |
| K091921 | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP | Codman & Shurtleff, Inc. | Sep 8, 2009 | SESE |
| K081640 | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS | Gimmi GmbH | May 6, 2009 | SESE |
| K081489 | L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS | Peter Lazic GmbH | Sep 25, 2008 | SESE |
| K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS | Kirwan Surgical Products, Inc. | Apr 17, 2007 | SESE |
| K043041 | AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) | Aesculap, Inc. | Dec 9, 2004 | SESE |
| K032198 | AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP | Aesculap, Inc. | Aug 20, 2003 | SESE |
| K031468 | TEMPORARY TITANIUM ANEURYSM CLIP | Cardinalhealth | Jun 20, 2003 | SESE |
| K024349 | AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER | Aesculap, Inc. | Mar 24, 2003 | SESE |
| K013136 | ANEURYSM CLIPS | Gistlstrasse | Nov 26, 2001 | SESE |
| K010908 | MEDICON TITANIUM YASARGIL ANEURYSM CLIPS | Medicon EG | Aug 1, 2001 | SESE |
| K003500 | REBSTOCK YASARGIL ANEURYSM CLIP | Rebstock - Instrumente GmbH | May 30, 2001 | SESE |
| K003519 | YASARGIL PERMANENT ANEURYSM CLIPS | Aesculap, Inc. | Jan 29, 2001 | SESE |
| K002871 | MODIFICATION TO YASARGIL ANEURYSM CLIPS | Aesculap, Inc. | Oct 13, 2000 | SESE |
| K991959 | PSI TITANIUM ANEURYSM CLIP | V. Mueller Neuro/Spine | Jan 6, 2000 | SESE |
| K990202 | SUGITA TITANIUM ANEURYSM CLIP | Mizuho America, Inc. | Jun 4, 1999 | SESE |
| K983758 | YASARGIL TITANIUM ANEURYSM CLIPS | Aesculap, Inc. | Dec 18, 1998 | SESE |
| K972750 | TAKA ANEURYSM CLIP | V. Mueller Neuro/Spine | Jul 9, 1998 | SESE |
Top Applicants
- Aesculap, Inc. — 10 clearances
- Codman & Shurtleff, Inc. — 4 clearances
- Mizuho America, Inc. — 3 clearances
- Advanced Biosearch Assn. — 2 clearances
- Edward Weck, Inc. — 2 clearances
