HCH · Class II · 21 CFR 882.5200

FDA Product Code HCH: Clip, Aneurysm

Leading manufacturers include Aesculap, Inc., Codman & Shurtleff, Inc. and Edward Weck, 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 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 Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349
Aesculap, Inc.
Neurology · 84d
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 Dec 18, 1998
YASARGIL TITANIUM ANEURYSM CLIPS
K983758
Aesculap, Inc.
Neurology · 53d
Cleared Nov 26, 1997
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050
Aesculap, Inc.
Neurology · 324d
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
Cleared Mar 11, 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765
Aesculap, Inc.
Neurology · 202d
Cleared Nov 25, 1983
HEIFETZ INTRACRANIAL ANEURYSM CLIPS
K832795
Edward Weck, Inc.
Neurology · 99d
Cleared Oct 01, 1979
SCOVILLE-LEWIS ANEURYSM CLIPS
K791764
Codman & Shurtleff, Inc.
Neurology · 34d
Cleared Mar 16, 1979
HEIFETZ ANEURYSM CLIP, LMM BLADE
K790413
Edward Weck, Inc.
Neurology · 18d
Cleared Nov 12, 1976
OCCLUSION CLIPS
K760961
Codman & Shurtleff, Inc.
Neurology · 14d

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.