Sugita AVM Microclip Applier

FDA 510(k) K221524 · Mizuho America, Inc.

Substantially Equivalent

510(k) numberK221524

Submission

Device name
Sugita AVM Microclip Applier
Applicant
Mizuho America, Inc.
Union City, CA, US
Received
May 26, 2022
Decision date
June 24, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCI – Applier, Aneurysm Clip
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4175
Specialty
Neurology

Other 510(k)s with product code HCI

510(k)DeviceApplicantDecision
K211572Aesculap Slim Clip ApplierHCI · Traditional Aesculap, Inc.12/13/2021SE
K180914Aesculap Slim Clip ApplierHCI · Traditional Aesculap, Inc.04/17/2018SE
K173271Aesculap Slim Clip Applier ForcepsHCI · Special Aesculap, Inc.11/10/2017SE
K010910Medicon Yasargil Clip Applying ForcepsHCI · Traditional Medicon EG08/01/2001SE
K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754THCI · Traditional Nmt Medical, Inc.02/08/2000SE
K984109Aesculap Axial Clip ApplierHCI · Traditional Aesculap, Inc.02/12/1999SE
K982379Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional Johnson & Johnson Professionals, Inc.12/18/1998SE
K954658Perneczky Clip Applier/RemoverHCI · Traditional Von Zeppelin GmbH10/08/1996SE
K940970Yasargil, Caspar, Vario Clip AppliersHCI · Traditional Aesculap, Inc.01/24/1995SE
K902544Sundt Avm Micro ClipHCI · Traditional Codman & Shurtleff, Inc.09/20/1990SE

More from Codman & Shurtleff, Inc.

510(k)DeviceDecision
K211183Sugita AVM MicroclipsHCH · Traditional 03/02/2022SE
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 Microclip Applier cleared by the FDA?

Sugita AVM Microclip Applier (K221524) received a 510(k) decision of Substantially Equivalent on June 24, 2022, 29 days after the submission was received.

What is the product code of K221524?

The FDA product code is HCI – Applier, Aneurysm Clip, a Class II (moderate risk) device regulated under 21 CFR 882.4175.