Sugita AVM Microclips

FDA 510(k) K211183 · Mizuho America, Inc.

Substantially Equivalent

510(k) numberK211183

Submission

Device name
Sugita AVM Microclips
Applicant
Mizuho America, Inc.
Union City, CA, US
Received
April 20, 2021
Decision date
March 2, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCH – Clip, Aneurysm
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5200
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code HCH

510(k)DeviceApplicantDecision
K180757D-Clip; D-Clip ApplierHCH · Traditional Peter Lazic GmbH04/12/2019SE
K131500Yasargil Aneurysm Clips and Clip AppliersHCH · Traditional Aesculap, Inc.01/24/2014SE
K091921Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft…HCH · Special Codman & Shurtleff, Inc.09/08/2009SE
K081640Gimmi Aneurysm Clips and Applying ForcepsHCH · Abbreviated Gimmi GmbH05/06/2009SE
K081489L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil…HCH · Traditional Peter Lazic GmbH09/25/2008SE
K060915Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersHCH · Traditional Kirwan Surgical Products, Inc.04/17/2007SE
K043041Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)HCH · Special Aesculap, Inc.12/09/2004SE
K032198Aesculap Yasargil Aneurysm Clip Phynox Booster ClipHCH · Special Aesculap, Inc.08/20/2003SE
K031468Temporary Titanium Aneurysm ClipHCH · Traditional Cardinalhealth06/20/2003SE
K024349Aesulap Kopitnik Avm Microclips and ApplierHCH · Traditional Aesculap, Inc.03/24/2003SE

More from Aesculap, Inc.

510(k)DeviceDecision
K221524Sugita AVM Microclip ApplierHCI · Special 06/24/2022SE
K990202Sugita Titanium Aneurysm ClipHCH · Traditional 06/04/1999SE
K960037Sugita Avm MicroclipHCH · Traditional 02/05/1997SE
K955012Mizuho Radiolucent Head FrameHBL · Traditional 09/12/1996SE

Questions and answers

When was Sugita AVM Microclips cleared by the FDA?

Sugita AVM Microclips (K211183) received a 510(k) decision of Substantially Equivalent on March 2, 2022, 316 days after the submission was received.

What is the product code of K211183?

The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.