Atlas FDA

HCH

36 FDA 510(k) clearances · Product code

120 daysmedian time to decision
378 days90th percentile
36clearances measured

FDA profile

Official device name
Clip, Aneurysm
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5200
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2006: 7 · 2010: 4 · 2014: 13 · 2015: 9 · 2018: 19 · 2021: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Sugita AVM Microclips (K211183)Mizuho America, Inc.2022-03-02
D-Clip; D-Clip Applier (K180757)Peter Lazic GmbH2019-04-12
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (K131500)Aesculap, Inc.2014-01-24
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP (K091921)Codman & Shurtleff, Inc.2009-09-08
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (K081640)Gimmi GmbH2009-05-06
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS (K081489)Peter Lazic GmbH2008-09-25
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS (K060915)Kirwan Surgical Products, Inc.2007-04-17
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (K043041)Aesculap, Inc.2004-12-09
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (K032198)Aesculap, Inc.2003-08-20
TEMPORARY TITANIUM ANEURYSM CLIP (K031468)Cardinalhealth2003-06-20
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (K024349)Aesculap, Inc.2003-03-24
ANEURYSM CLIPS (K013136)Gistlstrasse2001-11-26
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (K010908)Medicon EG2001-08-01
REBSTOCK YASARGIL ANEURYSM CLIP (K003500)Rebstock - Instrumente GmbH2001-05-30
YASARGIL PERMANENT ANEURYSM CLIPS (K003519)Aesculap, Inc.2001-01-29
MODIFICATION TO YASARGIL ANEURYSM CLIPS (K002871)Aesculap, Inc.2000-10-13
PSI TITANIUM ANEURYSM CLIP (K991959)V. Mueller Neuro/Spine2000-01-06
SUGITA TITANIUM ANEURYSM CLIP (K990202)Mizuho America, Inc.1999-06-04
YASARGIL TITANIUM ANEURYSM CLIPS (K983758)Aesculap, Inc.1998-12-18
TAKA ANEURYSM CLIP (K972750)V. Mueller Neuro/Spine1998-07-09
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) (K970050)Aesculap, Inc.1997-11-26
SUGITA AVM MICROCLIP (K960037)Mizuho America, Inc.1997-02-05
SPETZLER TI 100 ANEURYSM CLIP (K955064)Elekta Instruments, Inc.1996-10-17
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (K960372)Scanlan Intl., Inc.1996-04-26
SUNDT SLIM-LINE GRAFT CLIPS (K912456)Codman & Shurtleff, Inc.1995-03-10
YASARGIL ANEURYSM CLIPS (K922272)Aesculap, Inc.1992-09-15
YASARGIL ANEURYSM CLIPS, MODIFICATION (K913765)Aesculap, Inc.1992-03-11
PERNECZKY ANEURYSM CLIP (K901312)Von Zeppelin GmbH1990-08-17
SUNDT-KEES REINFORCING ANEURYSM CLIP (K844352)Kees Surgical Specialty Co., Inc.1985-01-24
YASARGIL FENESTRATED ANEURYSM CLIP & (K833652)Advanced Biosearch Assn.1984-01-27
YASARGIL STANDARD ANEURYSM CLIP & (K833650)Advanced Biosearch Assn.1984-01-18
HEIFETZ INTRACRANIAL ANEURYSM CLIPS (K832795)Edward Weck, Inc.1983-11-25
SCOVILLE-LEWIS ANEURYSM CLIPS (K791764)Codman & Shurtleff, Inc.1979-10-01
HEIFETZ ANEURYSM CLIP, LMM BLADE (K790413)Edward Weck, Inc.1979-03-16
YASARGIL ANEURYSM CLIPS (K772200)Aesculap Instruments Corp.1977-12-08
OCCLUSION CLIPS (K760961)Codman & Shurtleff, Inc.1976-11-12

Track HCH automatically

Every clearance here is in the API, with alerts when new ones post.