Product Code: HCI FDA class 2 21 CFR 882.4175

Applier, Aneurysm Clip

Neurology

The Aneurysm Clip Applier is a surgical instrument used to precisely position and deploy aneurysm clips across the neck of an intracranial aneurysm during open neurosurgical procedures, allowing controlled placement and repositioning if needed before final deployment. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HCI under regulation 21 CFR 882.4175 in the Neurology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: HCI
Device Class: FDA class 2
Regulation Number: 882.4175
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 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221524	Sugita AVM Microclip Applier	Jun 24, 2022	Substantially Equivalent	Mizuho America, Inc.
K211572	Aesculap Slim Clip Applier	Dec 13, 2021	Substantially Equivalent	Aesculap, Inc.
K180914	Aesculap Slim Clip Applier	Apr 17, 2018	Substantially Equivalent	Aesculap, Inc.
K173271	Aesculap Slim Clip Applier Forceps	Nov 10, 2017	Substantially Equivalent	Aesculap, Inc.
K010910	MEDICON YASARGIL CLIP APPLYING FORCEPS	Aug 01, 2001	Substantially Equivalent	Medicon EG
K994191	SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T	Feb 08, 2000	Substantially Equivalent	Nmt Medical, Inc.
K984109	AESCULAP AXIAL CLIP APPLIER	Feb 12, 1999	Substantially Equivalent	Aesculap, Inc.
K982379	SUNDT SLIM-LINE ANEURYSM CLIP APPLIER	Dec 18, 1998	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K954658	PERNECZKY CLIP APPLIER/REMOVER	Oct 08, 1996	Substantially Equivalent	Von Zeppelin GmbH
K940970	YASARGIL, CASPAR, VARIO CLIP APPLIERS	Jan 24, 1995	Substantially Equivalent	Aesculap, Inc.
K902544	SUNDT AVM MICRO CLIP	Sep 20, 1990	Substantially Equivalent	Codman & Shurtleff, Inc.
K881912	SANO CLIP APPLIERS & REMOVERS	Jun 06, 1988	Substantially Equivalent	Downs Surgical , Ltd.
K881911	NEW SIZES SUGITA CLIPS	Jun 06, 1988	Substantially Equivalent	Downs Surgical , Ltd.
K833651	CLIP APPLYING FORCEPS	Nov 29, 1983	Substantially Equivalent	Advanced Biosearch Assn.