HCI · Class II · 21 CFR 882.4175

FDA Product Code HCI: Applier, Aneurysm Clip

Leading manufacturers include Aesculap, Inc., Codman & Shurtleff, Inc. and Johnson & Johnson Professionals, 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
1–14 of 14
Cleared Jun 24, 2022
Sugita AVM Microclip Applier
K221524
Mizuho America, Inc.
Neurology · 29d
Cleared Dec 13, 2021
Aesculap Slim Clip Applier
K211572
Aesculap, Inc.
Neurology · 206d
Cleared Apr 17, 2018
Aesculap Slim Clip Applier
K180914
Aesculap, Inc.
Neurology · 8d
Cleared Nov 10, 2017
Aesculap Slim Clip Applier Forceps
K173271
Aesculap, Inc.
Neurology · 29d
Cleared Feb 12, 1999
AESCULAP AXIAL CLIP APPLIER
K984109
Aesculap, Inc.
Neurology · 87d
Cleared Dec 18, 1998
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379
Johnson & Johnson Professionals, Inc.
Neurology · 163d
Cleared Jan 24, 1995
YASARGIL, CASPAR, VARIO CLIP APPLIERS
K940970
Aesculap, Inc.
Neurology · 328d
Cleared Sep 20, 1990
SUNDT AVM MICRO CLIP
K902544
Codman & Shurtleff, Inc.
Neurology · 106d

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.