Product Code: HCH FDA class 2 21 CFR 882.5200

Clip, Aneurysm

Neurology

The Aneurysm Clip is a permanently implanted neurosurgical device placed across the neck of an intracranial aneurysm during open surgery to exclude it from the cerebral circulation and prevent rupture or rebleeding. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is HCH under regulation 21 CFR 882.5200 in the Neurology specialty. The implant flag is active for this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HCH
Device Class: FDA class 2
Regulation Number: 882.5200
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K211183	Sugita AVM Microclips	Mar 02, 2022	Substantially Equivalent	Mizuho America, Inc.
K180757	D-Clip; D-Clip Applier	Apr 12, 2019	Substantially Equivalent	Peter Lazic GmbH
K131500	YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS	Jan 24, 2014	Substantially Equivalent	Aesculap, Inc.
K091921	CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP	Sep 08, 2009	Substantially Equivalent	Codman & Shurtleff, Inc.
K081640	GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS	May 06, 2009	Substantially Equivalent	Gimmi GmbH
K081489	L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS	Sep 25, 2008	Substantially Equivalent	Peter Lazic GmbH
K060915	KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS	Apr 17, 2007	Substantially Equivalent	Kirwan Surgical Products, Inc.
K043041	AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)	Dec 09, 2004	Substantially Equivalent	Aesculap, Inc.
K032198	AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP	Aug 20, 2003	Substantially Equivalent	Aesculap, Inc.
K031468	TEMPORARY TITANIUM ANEURYSM CLIP	Jun 20, 2003	Substantially Equivalent	Cardinalhealth
K024349	AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER	Mar 24, 2003	Substantially Equivalent	Aesculap, Inc.
K013136	ANEURYSM CLIPS	Nov 26, 2001	Substantially Equivalent	Gistlstrasse
K010908	MEDICON TITANIUM YASARGIL ANEURYSM CLIPS	Aug 01, 2001	Substantially Equivalent	Medicon EG
K003500	REBSTOCK YASARGIL ANEURYSM CLIP	May 30, 2001	Substantially Equivalent	Rebstock - Instrumente GmbH
K003519	YASARGIL PERMANENT ANEURYSM CLIPS	Jan 29, 2001	Substantially Equivalent	Aesculap, Inc.
K002871	MODIFICATION TO YASARGIL ANEURYSM CLIPS	Oct 13, 2000	Substantially Equivalent	Aesculap, Inc.
K991959	PSI TITANIUM ANEURYSM CLIP	Jan 06, 2000	Substantially Equivalent	V. Mueller Neuro/Spine
K990202	SUGITA TITANIUM ANEURYSM CLIP	Jun 04, 1999	Substantially Equivalent	Mizuho America, Inc.
K983758	YASARGIL TITANIUM ANEURYSM CLIPS	Dec 18, 1998	Substantially Equivalent	Aesculap, Inc.
K972750	TAKA ANEURYSM CLIP	Jul 09, 1998	Substantially Equivalent	V. Mueller Neuro/Spine
K970050	YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)	Nov 26, 1997	Substantially Equivalent	Aesculap, Inc.
K960037	SUGITA AVM MICROCLIP	Feb 05, 1997	Substantially Equivalent	Mizuho America, Inc.
K955064	SPETZLER TI 100 ANEURYSM CLIP	Oct 17, 1996	Substantially Equivalent	Elekta Instruments, Inc.
K960372	SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM	Apr 26, 1996	Substantially Equivalent	Scanlan Intl., Inc.
K912456	SUNDT SLIM-LINE GRAFT CLIPS	Mar 10, 1995	Substantially Equivalent	Codman & Shurtleff, Inc.
K922272	YASARGIL ANEURYSM CLIPS	Sep 15, 1992	Substantially Equivalent	Aesculap, Inc.
K913765	YASARGIL ANEURYSM CLIPS, MODIFICATION	Mar 11, 1992	Substantially Equivalent	Aesculap, Inc.
K901312	PERNECZKY ANEURYSM CLIP	Aug 17, 1990	Substantially Equivalent	Von Zeppelin GmbH
K844352	SUNDT-KEES REINFORCING ANEURYSM CLIP	Jan 24, 1985	Substantially Equivalent	Kees Surgical Specialty Co., Inc.
K833652	YASARGIL FENESTRATED ANEURYSM CLIP &	Jan 27, 1984	Substantially Equivalent	Advanced Biosearch Assn.
K833650	YASARGIL STANDARD ANEURYSM CLIP &	Jan 18, 1984	Substantially Equivalent	Advanced Biosearch Assn.
K832795	HEIFETZ INTRACRANIAL ANEURYSM CLIPS	Nov 25, 1983	Substantially Equivalent	Edward Weck, Inc.
K791764	SCOVILLE-LEWIS ANEURYSM CLIPS	Oct 01, 1979	Substantially Equivalent	Codman & Shurtleff, Inc.
K790413	HEIFETZ ANEURYSM CLIP, LMM BLADE	Mar 16, 1979	Substantially Equivalent	Edward Weck, Inc.
K772200	YASARGIL ANEURYSM CLIPS	Dec 08, 1977	Substantially Equivalent	Aesculap Instruments Corp.
K760961	OCCLUSION CLIPS	Nov 12, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.