HCH · Class II · 21 CFR 882.5200

FDA Product Code HCH: Clip, Aneurysm

Leading manufacturers include Aesculap, Inc., Codman & Shurtleff, Inc. and Mizuho America, Inc..

36
Total
36
Cleared
187d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Clip, Aneurysm Devices (Product Code HCH)

36 devices
1–24 of 36
Cleared Mar 02, 2022
Sugita AVM Microclips
K211183
Mizuho America, Inc.
Neurology · 316d
Cleared Apr 12, 2019
D-Clip
K180757
Peter Lazic GmbH
Neurology · 386d
Cleared Jan 24, 2014
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500
Aesculap, Inc.
Neurology · 245d
Cleared Sep 08, 2009
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
K091921
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared May 06, 2009
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
K081640
Gimmi GmbH
Neurology · 329d
Cleared Sep 25, 2008
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
K081489
Peter Lazic GmbH
Neurology · 120d
Cleared Apr 17, 2007
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
K060915
Kirwan Surgical Products, Inc.
Neurology · 378d
Cleared Dec 09, 2004
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
K043041
Aesculap, Inc.
Neurology · 35d
Cleared Aug 20, 2003
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198
Aesculap, Inc.
Neurology · 33d
Cleared Jun 20, 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468
Cardinalhealth
Neurology · 42d
Cleared Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349
Aesculap, Inc.
Neurology · 84d
Cleared Aug 01, 2001
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908
Medicon EG
Neurology · 128d
Cleared Jan 29, 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519
Aesculap, Inc.
Neurology · 75d
Cleared Oct 13, 2000
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871
Aesculap, Inc.
Neurology · 29d
Cleared Jan 06, 2000
PSI TITANIUM ANEURYSM CLIP
K991959
V. Mueller Neuro/Spine
Neurology · 210d
Cleared Jun 04, 1999
SUGITA TITANIUM ANEURYSM CLIP
K990202
Mizuho America, Inc.
Neurology · 134d
Cleared Dec 18, 1998
YASARGIL TITANIUM ANEURYSM CLIPS
K983758
Aesculap, Inc.
Neurology · 53d
Cleared Jul 09, 1998
TAKA ANEURYSM CLIP
K972750
V. Mueller Neuro/Spine
Neurology · 351d
Cleared Nov 26, 1997
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050
Aesculap, Inc.
Neurology · 324d
Cleared Feb 05, 1997
SUGITA AVM MICROCLIP
K960037
Mizuho America, Inc.
Neurology · 399d
Cleared Oct 17, 1996
SPETZLER TI 100 ANEURYSM CLIP
K955064
Elekta Instruments, Inc.
Neurology · 346d
Cleared Apr 26, 1996
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
K960372
Scanlan Intl., Inc.
Neurology · 91d
Cleared Mar 10, 1995
SUNDT SLIM-LINE GRAFT CLIPS
K912456
Codman & Shurtleff, Inc.
Neurology · 1376d
Cleared Sep 15, 1992
YASARGIL ANEURYSM CLIPS
K922272
Aesculap, Inc.
Neurology · 124d

About Product Code HCH - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code HCH since 1976, with 36 receiving FDA clearance (average review time: 187 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.