FDA Product Code HCI: Applier, Aneurysm Clip
Leading manufacturers include Aesculap, Inc., Downs Surgical , Ltd. and Codman & Shurtleff, Inc..
14
Total
14
Cleared
114d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Applier, Aneurysm Clip Devices (Product Code HCI)
14 devices
Cleared
Jun 24, 2022
Sugita AVM Microclip Applier
Mizuho America, Inc.
Neurology
29d
Cleared
Dec 13, 2021
Aesculap Slim Clip Applier
Aesculap, Inc.
Neurology
206d
Cleared
Apr 17, 2018
Aesculap Slim Clip Applier
Aesculap, Inc.
Neurology
8d
Cleared
Nov 10, 2017
Aesculap Slim Clip Applier Forceps
Aesculap, Inc.
Neurology
29d
Cleared
Aug 01, 2001
MEDICON YASARGIL CLIP APPLYING FORCEPS
Medicon EG
Neurology
128d
Cleared
Feb 08, 2000
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
Nmt Medical, Inc.
Neurology
57d
Cleared
Feb 12, 1999
AESCULAP AXIAL CLIP APPLIER
Aesculap, Inc.
Neurology
87d
Cleared
Dec 18, 1998
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
Johnson & Johnson Professionals, Inc.
Neurology
163d
Cleared
Oct 08, 1996
PERNECZKY CLIP APPLIER/REMOVER
Von Zeppelin GmbH
Neurology
364d
Cleared
Jan 24, 1995
YASARGIL, CASPAR, VARIO CLIP APPLIERS
Aesculap, Inc.
Neurology
328d
Cleared
Sep 20, 1990
SUNDT AVM MICRO CLIP
Codman & Shurtleff, Inc.
Neurology
106d
Cleared
Jun 06, 1988
NEW SIZES SUGITA CLIPS
Downs Surgical , Ltd.
Neurology
28d
Cleared
Jun 06, 1988
SANO CLIP APPLIERS & REMOVERS
Downs Surgical , Ltd.
Neurology
28d
Cleared
Nov 29, 1983
CLIP APPLYING FORCEPS
Advanced Biosearch Assn.
Neurology
41d
About Product Code HCI - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code HCI since 1983, with 14 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.