Cleared Traditional

Sugita AVM Microclips

K211183 · Mizuho America, Inc. · Neurology
Mar 2022
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K211183 is an FDA 510(k) clearance for the Sugita AVM Microclips, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Mizuho America, Inc. (Union City, US). The FDA issued a Cleared decision on March 2, 2022, 316 days after receiving the submission on April 20, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number K211183 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2021
Decision Date March 02, 2022
Days to Decision 316 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCH — Clip, Aneurysm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5200

Similar Devices — HCH Clip, Aneurysm

All 35
D-Clip; D-Clip Applier
K180757 · Peter Lazic GmbH · Apr 2019
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500 · Aesculap, Inc. · Jan 2014
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
K091921 · Codman & Shurtleff, Inc. · Sep 2009
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
K081640 · Gimmi GmbH · May 2009
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
K081489 · Peter Lazic GmbH · Sep 2008
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
K060915 · Kirwan Surgical Products, Inc. · Apr 2007