HCI · Applier, Aneurysm Clip
Neurology · 21 CFR 882.4175 · Class 2
Overview
| Product Code | HCI |
|---|---|
| Device Name | Applier, Aneurysm Clip |
| Regulation | 21 CFR 882.4175 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | Jun 24, 2022 | SESE |
| K211572 | Aesculap Slim Clip Applier | Aesculap, Inc. | Dec 13, 2021 | SESE |
| K180914 | Aesculap Slim Clip Applier | Aesculap, Inc. | Apr 17, 2018 | SESE |
| K173271 | Aesculap Slim Clip Applier Forceps | Aesculap, Inc. | Nov 10, 2017 | SESE |
| K010910 | MEDICON YASARGIL CLIP APPLYING FORCEPS | Medicon EG | Aug 1, 2001 | SESE |
| K994191 | SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T | Nmt Medical, Inc. | Feb 8, 2000 | SESE |
| K984109 | AESCULAP AXIAL CLIP APPLIER | Aesculap, Inc. | Feb 12, 1999 | SESE |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Johnson & Johnson Professionals, Inc. | Dec 18, 1998 | SESE |
| K954658 | PERNECZKY CLIP APPLIER/REMOVER | Von Zeppelin GmbH | Oct 8, 1996 | SESE |
| K940970 | YASARGIL, CASPAR, VARIO CLIP APPLIERS | Aesculap, Inc. | Jan 24, 1995 | SESE |
| K902544 | SUNDT AVM MICRO CLIP | Codman & Shurtleff, Inc. | Sep 20, 1990 | SESE |
| K881912 | SANO CLIP APPLIERS & REMOVERS | Downs Surgical , Ltd. | Jun 6, 1988 | SESE |
| K881911 | NEW SIZES SUGITA CLIPS | Downs Surgical , Ltd. | Jun 6, 1988 | SESE |
| K833651 | CLIP APPLYING FORCEPS | Advanced Biosearch Assn. | Nov 29, 1983 | SESE |
Top Applicants
- Aesculap, Inc. — 5 clearances
- Downs Surgical , Ltd. — 2 clearances
- Advanced Biosearch Assn. — 1 clearance
- Codman & Shurtleff, Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
