Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HCH — Predicate Candidate Screening

36 FDA 510(k) clearances under this product code; the 50 most recent screened below.

120 daysmedian FDA review time

378 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211183	Sugita AVM Microclips	Mizuho America, Inc.	2022-03-02	316	0
K180757	D-Clip; D-Clip Applier	Peter Lazic GmbH	2019-04-12	386	3
K131500	YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS	Aesculap, Inc.	2014-01-24	245	0
K091921	CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN	Codman & Shurtleff, Inc.	2009-09-08	70	0
K081640	GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS	Gimmi GmbH	2009-05-06	329	0
K081489	L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL	Peter Lazic GmbH	2008-09-25	120	2
K060915	KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE AN	Kirwan Surgical Products, Inc.	2007-04-17	378	0
K043041	AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)	Aesculap, Inc.	2004-12-09	35	0
K032198	AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP	Aesculap, Inc.	2003-08-20	33	0
K031468	TEMPORARY TITANIUM ANEURYSM CLIP	Cardinalhealth	2003-06-20	42	0
K024349	AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER	Aesculap, Inc.	2003-03-24	84	0
K013136	ANEURYSM CLIPS	Gistlstrasse	2001-11-26	68	0
K010908	MEDICON TITANIUM YASARGIL ANEURYSM CLIPS	Medicon EG	2001-08-01	128	0
K003500	REBSTOCK YASARGIL ANEURYSM CLIP	Rebstock - Instrumente GmbH	2001-05-30	198	0
K003519	YASARGIL PERMANENT ANEURYSM CLIPS	Aesculap, Inc.	2001-01-29	75	0
K002871	MODIFICATION TO YASARGIL ANEURYSM CLIPS	Aesculap, Inc.	2000-10-13	29	0
K991959	PSI TITANIUM ANEURYSM CLIP	V. Mueller Neuro/Spine	2000-01-06	210	0
K990202	SUGITA TITANIUM ANEURYSM CLIP	Mizuho America, Inc.	1999-06-04	134	2
K983758	YASARGIL TITANIUM ANEURYSM CLIPS	Aesculap, Inc.	1998-12-18	53	0
K972750	TAKA ANEURYSM CLIP	V. Mueller Neuro/Spine	1998-07-09	351	0
K970050	YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)	Aesculap, Inc.	1997-11-26	324	0
K960037	SUGITA AVM MICROCLIP	Mizuho America, Inc.	1997-02-05	399	0
K955064	SPETZLER TI 100 ANEURYSM CLIP	Elekta Instruments, Inc.	1996-10-17	346	0
K960372	SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM	Scanlan Intl., Inc.	1996-04-26	91	0
K912456	SUNDT SLIM-LINE GRAFT CLIPS	Codman & Shurtleff, Inc.	1995-03-10	1376	0
K922272	YASARGIL ANEURYSM CLIPS	Aesculap, Inc.	1992-09-15	124	0
K913765	YASARGIL ANEURYSM CLIPS, MODIFICATION	Aesculap, Inc.	1992-03-11	202	0
K901312	PERNECZKY ANEURYSM CLIP	Von Zeppelin GmbH	1990-08-17	150	0
K844352	SUNDT-KEES REINFORCING ANEURYSM CLIP	Kees Surgical Specialty Co., Inc.	1985-01-24	76	0
K833652	YASARGIL FENESTRATED ANEURYSM CLIP &	Advanced Biosearch Assn.	1984-01-27	100	0
K833650	YASARGIL STANDARD ANEURYSM CLIP &	Advanced Biosearch Assn.	1984-01-18	91	0
K832795	HEIFETZ INTRACRANIAL ANEURYSM CLIPS	Edward Weck, Inc.	1983-11-25	99	0
K791764	SCOVILLE-LEWIS ANEURYSM CLIPS	Codman & Shurtleff, Inc.	1979-10-01	34	0
K790413	HEIFETZ ANEURYSM CLIP, LMM BLADE	Edward Weck, Inc.	1979-03-16	18	0
K772200	YASARGIL ANEURYSM CLIPS	Aesculap Instruments Corp.	1977-12-08	9	0
K760961	OCCLUSION CLIPS	Codman & Shurtleff, Inc.	1976-11-12	14	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda