HCI — Applier, Aneurysm Clip Class II
FDA product code HCI covers "Applier, Aneurysm Clip", a Class II medical device regulated under 21 CFR 882.4175. Submissions are reviewed by the Neurology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HCI
- Device Class
- Class II
- Regulation Number
- 882.4175
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221524 | mizuho america | Sugita AVM Microclip Applier | June 24, 2022 |
| K211572 | aesculap | Aesculap Slim Clip Applier | December 13, 2021 |
| K180914 | aesculap | Aesculap Slim Clip Applier | April 17, 2018 |
| K173271 | aesculap | Aesculap Slim Clip Applier Forceps | November 10, 2017 |
| K010910 | medicon eg | MEDICON YASARGIL CLIP APPLYING FORCEPS | August 1, 2001 |
| K994191 | nmt medical | SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T | February 8, 2000 |
| K984109 | aesculap | AESCULAP AXIAL CLIP APPLIER | February 12, 1999 |
| K982379 | johnson and johnson professionals | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | December 18, 1998 |
| K954658 | von zeppelin | PERNECZKY CLIP APPLIER/REMOVER | October 8, 1996 |
| K940970 | aesculap | YASARGIL, CASPAR, VARIO CLIP APPLIERS | January 24, 1995 |
| K902544 | codman and shurtleff | SUNDT AVM MICRO CLIP | September 20, 1990 |
| K881911 | downs surgical | NEW SIZES SUGITA CLIPS | June 6, 1988 |
| K881912 | downs surgical | SANO CLIP APPLIERS & REMOVERS | June 6, 1988 |
| K833651 | advanced biosearch assn | CLIP APPLYING FORCEPS | November 29, 1983 |